Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

Purpose: The minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC). Methods: In this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question. Results: For the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively. Conclusion: In this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care

Outcomes of open repair of postdissection abdominal aortic aneurysms

Background: Evidence to guide management of postdissection abdominal aortic aneurysms (PDAAA) is lacking. This study describes the outcomes of open repair of PDAAA. Methods: A retrospective cohort study was conducted of all consecutive patients treated with open repair for PDAAA after a Stanford type A or type B thoracic aortic dissection between January 2006 and December 2017 in two vascular referral centers. Preceding type B dissection treatment could include conservative or surgical management. Primary outcomes were 30-day mortality, complication rates, survival, and reintervention-free survival. Survival and reintervention-free survival were analyzed using the Kaplan-Meier method. Reintervention was defined as any endovascular or surgical intervention after the index procedure. Results: Included were 36 patients (27 men [75%]) with a median age of 64 years (range, 35-81 years). The 30-day mortality was 2.7%. The median follow-up was 16 months (range, 0-88 months). The postoperative course was uneventful in 21 patients (58%). The most frequent complications were postoperative bleeding requiring repeat laparotomy (n = 4), pneumonia (n = 3), congestive heart failure (n = 2), new-onset atrial fibrillation (n = 2), mesenteric ischemia requiring left hemicolectomy (n=1), and ischemic cerebrovascular accident (n = 1). Renal failure requiring hemodialysis developed in one patient. The overall survival at 1 year was 88.8%. Reintervention-free survival was 95.5% after 1 year and 88.6% after 2 years. Conclusions: Open repair of PDAAA can be performed with a low mortality rate and an acceptable complication rate, comparable with elective open repair of abdominal aortic aneurysms without dissection

Type 2 Endoleak With or Without Intervention and Survival After Endovascular Aneurysm Repair

Objective: The aims of the present study were to examine the impact of type 2 endoleaks (T2EL) on overall survival and to determine the need for secondary intervention after endovascular aneurysm repair (EVAR). Methods: A multicentre retrospective cohort study in the Netherlands was conducted among patients with an infrarenal abdominal aortic aneurysm (AAA) who underwent EVAR between 2007 and 2012. The primary endpoint was overall survival for patients with (T2EL+) or without (T2EL-) a T2EL. Secondary endpoints were sac growth, AAA rupture, and secondary intervention. Kaplan–Meier survival and multivariable Cox regression analysis were used. Results: A total of 2 018 patients were included. The median follow up was 62.1 (range 0.1 – 146.2) months. No difference in overall survival was found between T2EL+ (n = 388) and T2EL- patients (n = 1630) (p =.54). The overall survival estimates at five and 10 years were 73.3%/69.4% and 45.9%/44.1% for T2EL+/T2EL- patients, respectively. Eighty-five of 388 (21.9%) T2EL+ patients underwent a secondary intervention. There was no difference in overall survival between T2EL+ patients who underwent a secondary intervention and those who were treated conservatively (p =.081). Sac growth was observed in 89 T2EL+ patients and 44/89 patients (49.4%) underwent a secondary intervention. In 41/44 cases (93.1%), sac growth was still observed after the intervention, but was left untreated. Aneurysm rupture occurred in 4/388 T2EL patients. In Cox regression analysis, higher age, ASA classification, and maximum iliac diameter were significantly associated with worse overall survival. Conclusion: No difference in overall survival was found between T2EL+ and T2EL- patients. Also, patients who underwent a secondary intervention did not have better survival compared with those who did not undergo a secondary intervention. This study reinforces the need for conservative treatment of an isolated T2EL and the importance of a prospective study to determine possible advantages of the intervention

External validation of the Endovascular aneurysm repair Risk Assessment model in predicting survival, reinterventions, and endoleaks after endovascular aneurysm repair

The Endovascular aneurysm repair Risk Assessment (ERA) model predicts survival (early death, 3-year survival, and 5-year survival), reinterventions, and endoleaks after elective endovascular aneurysm repair. We externally validated the ERA model in our cohort of patients. This was a retrospective validation study of 433 consecutive patients with an asymptomatic abdominal aortic aneurysm treated with endovascular aneurysm repair in three hospitals (Amsterdam, The Netherlands) between 1997 and 2010. The area under the receiver operating characteristic curve was used as measure of accuracy (>0.70 was considered as sufficiently accurate). The early death rate was 1% (3 of 433; 95% confidence interval [CI], 0%-2%), the 5-year survival rate was 65% (95% CI, 61%-70%), the 5-year reintervention rate was 18% (95% CI, 14-78%), and the 5-year rate of type I, II, or III endoleak was 25% (95% CI, 20%-29%). The areas under the curve varied between 0.64 and 0.66 for predictions of survival and between 0.47 and 0.61 for reinterventions and endoleaks. The predictions of survival, reinterventions, and endoleaks made by the ERA model were not sufficiently accurate to be used in our clinical practic

Comparative study of venous arterialization and pedal bypass in a patient cohort with critical limb ischemia

Patients with critical limb ischemia (CLI) have a poor life expectancy, and aggressive revascularization is accepted as a means to maintain their independence in the end stage of life. The goal of this case-control study was to evaluate the clinical outcome of distal venous arterialization and compare this with pedal bypass surgery in patients with CLI, and to identify potential risk factors that could be used to effectively identify patients at high risk of graft occlusion and amputation. A retrospective cohort of patients was treated for CLI using venous arterialization or pedal bypass between 2007 and 2012. Kaplan-Meier and Cox regression analyses were used to evaluate predictors for limb salvage and patency. In 40 patients with CLI, 21 venous arterializations and 19 pedal bypasses were performed. In the venous arterialization group, early occlusion was 15%, 1-year patency was 71%, and limb salvage was 53%. In the PB group, early occlusion was 23%, one-year patency was 75% and limb salvage was 47%. The only independent risk factor for limb salvage in multivariate analysis was bypass occlusion (P <0.001). Limb salvage after venous arterialization was equal to limb salvage after pedal bypass surgery in this clinical comparative stud

Endovascular Repair Versus Open Repair of Ruptured Abdominal Aortic Aneurysms A Multicenter Randomized Controlled Trial

Objective: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). Background: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. Methods: All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. Results: Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. Conclusions: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertis

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

Background: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). Methods: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. Results: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). Conclusions: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future