Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Long-term results and predictors of failure after mechanochemical endovenous ablation in the treatment of primary great saphenous vein incompetence.

BACKGROUND: Mechanochemical endovenous ablation (MOCA) was introduced to treat superficial venous insufficiency of the lower leg with less pain and haematoma. Long-term outcome is still lacking. The purpose was to report long-term outcome and to analyse possible predictors for failure. METHODS: The study was a retrospective pooled analysis of two prospective cohorts previously reported, but with prolonged long-term outcome up to 5-years follow-up. RESULTS: 163 treated legs were analysed. Mean follow-up was 5.4±0.6 years, in which 33 total failures occurred. Four procedures were partially successful. VCSS improved significantly and remained stable after 1 and 2-years, but significantly rose again after 5-years. AVVQ dropped significantly, but increased after 1 year to 4.3 and 6.1 at 5-years follow-up. CONCLUSION: MOCA was effective with minimal pain perioperative. However, anatomical success deteriorated after 1-year and showed even less results after 5-years, mainly due to partly recanalization, while clinical results were less affected. There were no clear clinical predictors for failure.

Long-Term Outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique in Patients With Aorto-Iliac Occlusive Disease.

BACKGROUND: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. METHODS: Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. RESULTS: One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. CONCLUSION: The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. CLINICAL IMPACT: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.

BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

OBJECTIVE: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. METHODS: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. RESULTS: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. CONCLUSION: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

The relation between physical fitness, frailty and all-cause mortality after elective endovascular abdominal aortic aneurysm repair.

BACKGROUND: Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality. METHODS: Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses. RESULTS: There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho = 0.163; P = .001), but not between the METs and 1-year all-cause mortality (Rho = -0.083; P = .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho = 0.255; P < .001 and Rho = -0.154; P = .004). When stratified by the MFI-5, the 1- and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P = .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P = .090). The 5-year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P = .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution. CONCLUSIONS: There is a significant positive association between the MFI-5 and both the 1- and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.

Pulmonary complications and survival after elective infrarenal endovascular abdominal aneurysm repair in patients with documented chronic obstructive pulmonary disease.

BACKGROUND: Elective abdominal aortic aneurysm (AAA) repair is advocated in patients where risk of rupture exceeds the risks of peri-procedural morbidity and mortality. Chronic obstructive pulmonary disease (COPD) is a known risk factor for AAA and increased operative morbidity in general. Since literature on the correlation between the clinical classification of COPD and morbidity following endovascular infrarenal AAA repair (EVAR) is scarce, assessment per individual remains a challenge. OBJECTIVE: To analyse the pulmonary and all-cause morbidity and mortality in patients with documented COPD and relate this to their GOLD classification. METHODS: Sixty-eight patients with COPD, documented by a lung function test, who underwent elective EVAR between July 2002 and July 2018 were retrospectively reviewed. The primary endpoint was the incidence of 30-day pulmonary adverse events. Procedural characteristics, length of hospital stay, pulmonary and all-cause morbidity including major adverse events (MAEs) during follow-up and five-year survival divided per GOLD classification were the secondary endpoints. RESULTS: There was no statistically significant difference in the incidence of pulmonary adverse events between GOLD I/II and GOLD III/IV patients. There was neither procedural nor 30-day mortality in either group. Through 30 days and 1 year, there was no difference in pulmonary and all-cause morbidity between groups. Three MAEs occurred in the GOLD I/II group versus 2 MAE in the GOLD III/IV group during the first postoperative year. The five-year survival was 66.0%, 60.9% and 61.9% for patients with GOLD I, GOLD II and GOLD III, respectively. Three of four GOLD IV died within the first year after EVAR. CONCLUSION: EVAR can be safely performed in patients with COPD, with low 30-day morbidity and mortality rates. Although severe co-morbidity should be taken into account, EVAR seems to be justified in patients with COPD with a GOLD classification I, II or III. Further research should focus on optimising the pulmonary condition in patients selected for EVAR.

The Effect of Percutaneous Flexor Tenotomy on Healing and Prevention of Foot Ulcers in Patients With Claw Deformity of the Toe.

Claw deformity of the foot is frequently seen in patients with diabetes mellitus. Percutaneous flexor tenotomy is a simple surgical procedure for the treatment of foot ulcers on the distal end of the toe caused by this deformity. This procedure can also be performed to prevent ulcers in claw toes that are at risk of ulceration. The aim of this study is to investigate whether percutaneous flexor tenotomy is an effective surgical method for treatment and prevention of toe ulcers in patients with claw deformity. This retrospective study, with a median follow-up of 13.4 (1 to 66.7) months, included all consecutive patients who underwent percutaneous flexor tenotomy in 2 hospitals between July 2012 and April 2017. In total, 101 feet underwent flexor tenotomy: 84 (83.3%) therapeutic and 17 (16.7%) prophylactic. Of the 84 therapeutic procedures, 95.1% healed, with a median healing time of 27 days. In 11 (13.3%) therapeutic procedures, a reulceration was recorded. In the therapeutic group, 4 (4.8%) infections and 1 (1.2%) amputation of the digit occurred. In the 17 prophylactic procedures, local bleeding was recorded in 1 (5.9%). In the prophylactic group, 2 ulcers occurred. In 77 (76.2%) of all procedures, patients had diabetes mellitus. In conclusion, percutaneous flexor tenotomy is an effective, safe, and minimally invasive procedure for the treatment and prevention of toe ulcers in patients with claw deformity.