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Comparison of Long-term Outcomes of Heparin Bonded Polytetrafluoroethylene and Autologous Vein Below Knee Femoropopliteal Bypasses in Patients with Critical Limb Ischaemia
Selected Abstracts from the August Issue of the European Journal of Vascular and Endovascular Surgery Philippe H. Kolh, MD, PhD, EDITOR-IN-CHIEF, and Florian Dick, MD, SENIOR EDITOR Pre-operative Carotid Plaque Echolucency Assessment has no Predictive Value for Long-Term Risk of Stroke or Cardiovascular Death in Patients Undergoing Carotid Endarterectomy de Waard D, de Borst GJ, Bulbulia R, Pan H, Halliday A, on behalf of the ACST-1 collaborative group. Eur J Vasc Endovasc Surg 2017;54:135-41. Introduction: In patients with carotid stenosis receiving medical treatment, carotid plaque echolucency has been thought to predict risk of future stroke and of other cardiovascular events. This study evaluated the prognostic value of pre-operative plaque echolucency for future stroke and cardiovascular death in patients undergoing carotid endarterectomy in the first Asymptomatic Carotid Surgery Trial (ACST-1). Methods: In ACST-1, 1832/3120 patients underwent carotid endarterectomy (CEA), of whom 894 had visual echolucency assessment according to the Gray-Weale classification. During follow-up patients were monitored both for peri-procedural (i.e. within 30 days) death, stroke, or MI, and for long-term risk of stroke or cardiovascular death. Unconditional maximum likelihood estimation was used to calculate odds ratios of peri-procedural risk and Kaplan-Meier statistics with log-rank test were used to compare cumulative long-term risks. Results: Of 894 operated patients in whom echolucency was assessed, 458 plaques (51%) were rated as echolucent and peri-procedural risk of death/stroke/MI in these patients was non-significantly higher when compared with patients with non-echolucent plaques (OR 1.48 [95% CI 0.76e2.88], P = .241). No differences were found in the 10 year risk of any stroke (30/447 [11.6%] vs 29/433 [11.0%], P = .900) or cardiovascular (non-stroke) death (85/447 [27.9%] vs 93/433 [32.1%], P = .301). Conclusion: In ACST-1, carotid plaque echolucency assessment in patients undergoing CEA offered no predictive value with regard to peri-operative or long-term stroke risk or of cardiovascular (non-stroke) death.
Prolonged ICU Length of Stay after AAA Repair: Analysis of Time Trends and Long-term Outcome Gavali H, Mani K, Tegler G, Kawati R, Covaciu L, Wanhainen A. Eur J Vasc Endovasc Surg 2017;54:157-63. Objective: The aim of the study was to investigate the frequency and outcome of prolonged intensive care unit (ICU) length of stay (LOS) after abdominal aortic aneurysm (AAA) repair in the endovascular era. Methods: All patients operated on for AAA between 1999 and 2013 at Uppsala University hospital were identified. Data were retrieved from the Swedish Vascular registry, the Swedish Intensive Care registry, the National Population registry, and case records. Prolonged ICU LOS was defined as $ 48 h during the primary hospital stay. Patients surviving $ 48 h after AAA surgery were included in the analysis. Results: A total of 725 patients were identified, of whom 707 (97.5%) survived $ 48 h; 563 (79.6%) underwent intact AAA repair and 144 (20.4%) ruptured AAA repair. A total of 548 patients (77.5%) required < 48 h of intensive care, 115 (16.3%) 2e6 days and 44 (6.2%) $ 7 days. The rate of prolonged ICU LOS declined considerably over time, from 41.4% of all AAA repairs in 1999 to 7.3% in 2013 (P < .001) whereas the use of endovascular aortic repair (EVAR) increased from 6.9% in 1999 to 78.0% in 2013 (P < .001). The 30 day survival rate was 98.2% for those with < 48 h ICU stay versus 93.0% for 2e6 days versus 81.8% for $ 7 days (P < .001); the corresponding 90 day survival was 97.1% versus 86.1% versus 63.6% (P < .001) respectively. For patients surviving 90 days after repair, there was no difference in long-term survival between the groups. Conclusion: During the period of progressively increasing use of EVAR, a simultaneous significant reduction in frequency of prolonged ICU LOS occurred. Although prolonged ICU LOS was associated with a high shortterm mortality, long-term outcome among those surviving the initial 90 days was less affected.
Outcomes of Self Expanding PTFE Covered Stent Versus Bare Metal Stent for Chronic Iliac Artery Occlusion in Matched Cohorts Using Propensity Score Modelling Piazza M, Squizzato F, Dall’Antonia A, Lepidi S, Menegolo M, Grego F, Antonello M. Eur J Vasc Endovasc Surg 2017;54:177-85. Objectives: The aim was to compare outcomes of self expanding PTFE covered stents (CSs) with bare metal stents (BMSs) in the treatment of iliac artery occlusions (IAOs). Methods: Between January 2009 and December 2015, 128 iliac arteries were stented for IAO. A CS was implanted in 78 iliac arteries (61%) and a BMS in 50 (49%). After propensity score matching, 94 limbs were selected and underwent stenting (47 for each group). Thirty day outcomes and midterm patency were compared; follow-up results were analysed with KaplaneMeier curves. Results: Overall, iliac lesions were classified by limb as TASC B (19%), C (21%), and D (60%). Technical success was 98%. Comparing CS versus BMS, the early cumulative surgical complication rate (12% vs 12%, P = 1.0) and 30 day mortality rate (2% vs 2%, P = 1.0) were equivalent. At 36 months (average 23 6 17), overall primary patency was similar between CS and BMS (87% vs 66%, P = .06), and this finding was maintained after stratification by TASC B (P = .29) and C (P = .27), but for TASC D, CSs demonstrated a higher patency rate (CS, 88% vs BMS, 54%; P = .03). In particular, patency was in favour of CSs for IAOs > 3.5 cm in length (P = .04), total lesion length > 6 cm (P = .04), and IAO with calcification > 75% of the arterial wall circumference (P = .01). Conclusions: Overall, the use of self expanding CS for IAOs has similar early and midterm outcomes compared with BMS. Even if further confirmatory studies are needed, CSs seem to have higher midterm patency rates than BMSs for TASC D lesions, IAOs with a total lesion length > 6 cm, occlusion length > 3.5 cm, and calcification involving > 75% of the arterial wall circumference. These specific anatomical parameters may be useful to the operator when deciding between CS and BMS during endovascular planning.
Comparison of Long-term Outcomes of Heparin Bonded Polytetrafluoroethylene and Autologous Vein Below Knee Femoropopliteal Bypasses in Patients with Critical Limb Ischaemia Uhl C, Grosch C, Hock C, Töpel I, Steinbauer M. Eur J Vasc Endovasc Surg 2017;54:203-11. Objective/Background: Endovascular first is the preferred therapy approach to critical limb ischaemia (CLI). However, in spite of new endovascular techniques, bypass surgery still plays an important role, especially in patients with complex anatomy in whom endovascular therapy is not considered feasible, or has failed. The goal of this study was to analyse the outcomes of prosthetic or autologous vein for femoropopliteal (P3) bypasses performed under the abovementioned conditions. Methods: A retrospective analysis of patients who underwent a femoropopliteal (P3) bypass for CLI (March 2007eDecember 2015) was conducted. Endovascular therapy was not possible. Patency rates, limb salvage, major adverse limb event (MALE) free survival, and survival after 5 years were analysed. Results: In total, 151 cases were included in the analysis (rest pain 35.8%, ulcer/gangrene 64.3%). The graft material was autologous vein in 76 cases (vein group) and heparin bonded expanded polytetrafluoroethylene (HePTFE) in 75 cases (HePTFE group). Indications, risk factors, previous revascularisation procedures, and runoff vessels were similar in both groups. Thirty day mortality was 6.6% in the vein group and 5.3% in the HePTFE group (P = .508), early graft occlusion (6.6% vs 5.3%; P = .508) and 30 day major amputation rate (0% vs 2.7%; P = .245) were similar between the two groups. Overall primary patency was 51.7% (55.5% [vein group] vs 51.7% [HePTFE group]; P = .897) and overall secondary patency was 64.2% (74.6% [vein group] vs 55.6% [HePTFE group]; P = .119), all without significance after 5 years. However, limb salvage
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(79.1%) was significantly different (90.0% [vein group] vs 62.9% [HePTFE group]; P = .021). Survival was similar between the groups (47.3% vs 42.9%; P = .582) as well as MALE free survival (69.4% vs 55.0%; P = .348). Conclusion: Bypasses to the below knee popliteal artery show good results in patients with CLI unsuitable for endovascular therapy. Vein is still the first line graft material.
Systematic Review and Meta-Analysis of the Association Between C-Reactive Protein and Major Cardiovascular Events in Patients with Peripheral Artery Disease Singh TP, Morris DR, Smith S, Moxon JV, Golledge J. Eur J Vasc Endovasc Surg 2017;54:220-33. Background: Patients with peripheral artery disease (PAD) are at substantial risk of cardiovascular events. There is interest in using blood markers, such as C-reactive protein (CRP), to monitor prognosis and treatment efficacy in PAD patients. The aim of this meta-analysis was to assess the association between CRP and major cardiovascular events in PAD patients. Method: Studies evaluating the association between CRP and major cardiovascular events (myocardial infarction, stroke, cardiac revascularisation and mortality) were identified using MEDLINE and the Cochrane library. Studies that did not include participants with PAD, measure CRP, or follow-up patients for cardiovascular events were excluded. Meta-analyses of published adjusted hazard ratios (HR) were conducted using an inverse variance-weighted random effects model, and heterogeneity was assessed with the I2 index. Results: A total of 16 studies involving 5041 participants met the inclusion criteria for the systematic review. Eight studies were included in the meta-analyses. Summary effect estimates were reported as HR comparing higher and lower quantiles, and HR per unit increase in logeCRP. PAD patients with higher CRP had a significantly greater risk of major cardiovascular events compared with those with lower CRP (HR 2.26, 95% CI 1.65e3.09, P < 0.001). The HR for major cardiovascular events was 1.38 (95% CI 1.16e1.63, P < 0.001) per unit increase in logeCRP. Conclusions: The present findings suggest that high circulating CRP is predictive of major cardiovascular events in PAD patients.
A Simulator for Training in Endovascular Aneurysm Repair: The Use of Three Dimensional Printers Torres IO, De Luccia N. Eur J Vasc Endovasc Surg 2017;54:247-53. Objectives: To develop an endovascular aneurysm repair (EVAR) simulation system using three dimensional (3D) printed aneurysms, and to evaluate the impact of patient specific training prior to EVAR on the surgical performance of vascular surgery residents in a university hospital in Brazil. Methods: This was a prospective, controlled, single centre study. During 2015, the aneurysms of patients undergoing elective EVAR at São Paulo University Medical School were 3D printed and used in training sessions with vascular surgery residents. The 3D printers Stratasys-Connex 350, Formlabs-Form1+, and Makerbot were tested. Ten residents were enrolled in the control group (five residents and 30 patients in 2014) or the training group (five residents and 25 patients in 2015). The control group performed the surgery under the supervision of a senior vascular surgeon (routine procedure, without simulator training). The training group practised the surgery in a patient specific simulator prior to the routine procedure. Objective parameters were analysed, and a subjective questionnaire addressing training utility and realism was answered. Results: Patient specific training reduced fluoroscopy time by 30% (mean 48 min, 95% confidence interval [CI] 40e58 vs 33 min, 95% CI 26e42 [P < .01]), total procedure time by 29% (mean 292 min [95% CI 235e336] vs 207 [95% CI 173e247]; P < .01), and volume of contrast used by 25% (mean 87 mL [95% CI 73e103] vs 65 mL [95% CI 52e81]; P = .02). The residents considered the training useful and realistic, and reported that it increased their self confidence. The 3D printers Form1+ (using flexible resin) and Makerbot (using silicone) provided the best performance based on simulator quality and cost. Conclusion: An EVAR simulation system using 3D printed aneurysms was feasible. The best results were obtained with the 3D printers Form1+ (using flexible resin) and Makerbot (using silicone). Patient specific training prior to EVAR at a university hospital in Brazil improved residents’ surgical performance (based on fluoroscopy time, surgery time, and volume of contrast used) and increased their self confidence.
Prolonged ICU Length of Stay after AAA Repair: Analysis of Time Trends and Long-term Outcome Gavali H, Mani K, Tegler G, Kawati R, Covaciu L, Wanhainen A. Eur J Vasc Endovasc Surg 2017;54:157-63. Objective: The aim of the study was to investigate the frequency and outcome of prolonged intensive care unit (ICU) length of stay (LOS) after abdominal aortic aneurysm (AAA) repair in the endovascular era. Methods: All patients operated on for AAA between 1999 and 2013 at Uppsala University hospital were identified. Data were retrieved from the Swedish Vascular registry, the Swedish Intensive Care registry, the National Population registry, and case records. Prolonged ICU LOS was defined as $ 48 h during the primary hospital stay. Patients surviving $ 48 h after AAA surgery were included in the analysis. Results: A total of 725 patients were identified, of whom 707 (97.5%) survived $ 48 h; 563 (79.6%) underwent intact AAA repair and 144 (20.4%) ruptured AAA repair. A total of 548 patients (77.5%) required < 48 h of intensive care, 115 (16.3%) 2e6 days and 44 (6.2%) $ 7 days. The rate of prolonged ICU LOS declined considerably over time, from 41.4% of all AAA repairs in 1999 to 7.3% in 2013 (P < .001) whereas the use of endovascular aortic repair (EVAR) increased from 6.9% in 1999 to 78.0% in 2013 (P < .001). The 30 day survival rate was 98.2% for those with < 48 h ICU stay versus 93.0% for 2e6 days versus 81.8% for $ 7 days (P < .001); the corresponding 90 day survival was 97.1% versus 86.1% versus 63.6% (P < .001) respectively. For patients surviving 90 days after repair, there was no difference in long-term survival between the groups. Conclusion: During the period of progressively increasing use of EVAR, a simultaneous significant reduction in frequency of prolonged ICU LOS occurred. Although prolonged ICU LOS was associated with a high shortterm mortality, long-term outcome among those surviving the initial 90 days was less affected.
Outcomes of Self Expanding PTFE Covered Stent Versus Bare Metal Stent for Chronic Iliac Artery Occlusion in Matched Cohorts Using Propensity Score Modelling Piazza M, Squizzato F, Dall’Antonia A, Lepidi S, Menegolo M, Grego F, Antonello M. Eur J Vasc Endovasc Surg 2017;54:177-85. Objectives: The aim was to compare outcomes of self expanding PTFE covered stents (CSs) with bare metal stents (BMSs) in the treatment of iliac artery occlusions (IAOs). Methods: Between January 2009 and December 2015, 128 iliac arteries were stented for IAO. A CS was implanted in 78 iliac arteries (61%) and a BMS in 50 (49%). After propensity score matching, 94 limbs were selected and underwent stenting (47 for each group). Thirty day outcomes and midterm patency were compared; follow-up results were analysed with KaplaneMeier curves. Results: Overall, iliac lesions were classified by limb as TASC B (19%), C (21%), and D (60%). Technical success was 98%. Comparing CS versus BMS, the early cumulative surgical complication rate (12% vs 12%, P = 1.0) and 30 day mortality rate (2% vs 2%, P = 1.0) were equivalent. At 36 months (average 23 6 17), overall primary patency was similar between CS and BMS (87% vs 66%, P = .06), and this finding was maintained after stratification by TASC B (P = .29) and C (P = .27), but for TASC D, CSs demonstrated a higher patency rate (CS, 88% vs BMS, 54%; P = .03). In particular, patency was in favour of CSs for IAOs > 3.5 cm in length (P = .04), total lesion length > 6 cm (P = .04), and IAO with calcification > 75% of the arterial wall circumference (P = .01). Conclusions: Overall, the use of self expanding CS for IAOs has similar early and midterm outcomes compared with BMS. Even if further confirmatory studies are needed, CSs seem to have higher midterm patency rates than BMSs for TASC D lesions, IAOs with a total lesion length > 6 cm, occlusion length > 3.5 cm, and calcification involving > 75% of the arterial wall circumference. These specific anatomical parameters may be useful to the operator when deciding between CS and BMS during endovascular planning.
Comparison of Long-term Outcomes of Heparin Bonded Polytetrafluoroethylene and Autologous Vein Below Knee Femoropopliteal Bypasses in Patients with Critical Limb Ischaemia Uhl C, Grosch C, Hock C, Töpel I, Steinbauer M. Eur J Vasc Endovasc Surg 2017;54:203-11. Objective/Background: Endovascular first is the preferred therapy approach to critical limb ischaemia (CLI). However, in spite of new endovascular techniques, bypass surgery still plays an important role, especially in patients with complex anatomy in whom endovascular therapy is not considered feasible, or has failed. The goal of this study was to analyse the outcomes of prosthetic or autologous vein for femoropopliteal (P3) bypasses performed under the abovementioned conditions. Methods: A retrospective analysis of patients who underwent a femoropopliteal (P3) bypass for CLI (March 2007eDecember 2015) was conducted. Endovascular therapy was not possible. Patency rates, limb salvage, major adverse limb event (MALE) free survival, and survival after 5 years were analysed. Results: In total, 151 cases were included in the analysis (rest pain 35.8%, ulcer/gangrene 64.3%). The graft material was autologous vein in 76 cases (vein group) and heparin bonded expanded polytetrafluoroethylene (HePTFE) in 75 cases (HePTFE group). Indications, risk factors, previous revascularisation procedures, and runoff vessels were similar in both groups. Thirty day mortality was 6.6% in the vein group and 5.3% in the HePTFE group (P = .508), early graft occlusion (6.6% vs 5.3%; P = .508) and 30 day major amputation rate (0% vs 2.7%; P = .245) were similar between the two groups. Overall primary patency was 51.7% (55.5% [vein group] vs 51.7% [HePTFE group]; P = .897) and overall secondary patency was 64.2% (74.6% [vein group] vs 55.6% [HePTFE group]; P = .119), all without significance after 5 years. However, limb salvage
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(79.1%) was significantly different (90.0% [vein group] vs 62.9% [HePTFE group]; P = .021). Survival was similar between the groups (47.3% vs 42.9%; P = .582) as well as MALE free survival (69.4% vs 55.0%; P = .348). Conclusion: Bypasses to the below knee popliteal artery show good results in patients with CLI unsuitable for endovascular therapy. Vein is still the first line graft material.
Systematic Review and Meta-Analysis of the Association Between C-Reactive Protein and Major Cardiovascular Events in Patients with Peripheral Artery Disease Singh TP, Morris DR, Smith S, Moxon JV, Golledge J. Eur J Vasc Endovasc Surg 2017;54:220-33. Background: Patients with peripheral artery disease (PAD) are at substantial risk of cardiovascular events. There is interest in using blood markers, such as C-reactive protein (CRP), to monitor prognosis and treatment efficacy in PAD patients. The aim of this meta-analysis was to assess the association between CRP and major cardiovascular events in PAD patients. Method: Studies evaluating the association between CRP and major cardiovascular events (myocardial infarction, stroke, cardiac revascularisation and mortality) were identified using MEDLINE and the Cochrane library. Studies that did not include participants with PAD, measure CRP, or follow-up patients for cardiovascular events were excluded. Meta-analyses of published adjusted hazard ratios (HR) were conducted using an inverse variance-weighted random effects model, and heterogeneity was assessed with the I2 index. Results: A total of 16 studies involving 5041 participants met the inclusion criteria for the systematic review. Eight studies were included in the meta-analyses. Summary effect estimates were reported as HR comparing higher and lower quantiles, and HR per unit increase in logeCRP. PAD patients with higher CRP had a significantly greater risk of major cardiovascular events compared with those with lower CRP (HR 2.26, 95% CI 1.65e3.09, P < 0.001). The HR for major cardiovascular events was 1.38 (95% CI 1.16e1.63, P < 0.001) per unit increase in logeCRP. Conclusions: The present findings suggest that high circulating CRP is predictive of major cardiovascular events in PAD patients.
A Simulator for Training in Endovascular Aneurysm Repair: The Use of Three Dimensional Printers Torres IO, De Luccia N. Eur J Vasc Endovasc Surg 2017;54:247-53. Objectives: To develop an endovascular aneurysm repair (EVAR) simulation system using three dimensional (3D) printed aneurysms, and to evaluate the impact of patient specific training prior to EVAR on the surgical performance of vascular surgery residents in a university hospital in Brazil. Methods: This was a prospective, controlled, single centre study. During 2015, the aneurysms of patients undergoing elective EVAR at São Paulo University Medical School were 3D printed and used in training sessions with vascular surgery residents. The 3D printers Stratasys-Connex 350, Formlabs-Form1+, and Makerbot were tested. Ten residents were enrolled in the control group (five residents and 30 patients in 2014) or the training group (five residents and 25 patients in 2015). The control group performed the surgery under the supervision of a senior vascular surgeon (routine procedure, without simulator training). The training group practised the surgery in a patient specific simulator prior to the routine procedure. Objective parameters were analysed, and a subjective questionnaire addressing training utility and realism was answered. Results: Patient specific training reduced fluoroscopy time by 30% (mean 48 min, 95% confidence interval [CI] 40e58 vs 33 min, 95% CI 26e42 [P < .01]), total procedure time by 29% (mean 292 min [95% CI 235e336] vs 207 [95% CI 173e247]; P < .01), and volume of contrast used by 25% (mean 87 mL [95% CI 73e103] vs 65 mL [95% CI 52e81]; P = .02). The residents considered the training useful and realistic, and reported that it increased their self confidence. The 3D printers Form1+ (using flexible resin) and Makerbot (using silicone) provided the best performance based on simulator quality and cost. Conclusion: An EVAR simulation system using 3D printed aneurysms was feasible. The best results were obtained with the 3D printers Form1+ (using flexible resin) and Makerbot (using silicone). Patient specific training prior to EVAR at a university hospital in Brazil improved residents’ surgical performance (based on fluoroscopy time, surgery time, and volume of contrast used) and increased their self confidence.