Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis.

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[A swollen leg because of an aortocaval fistula]. / Een gezwollen been door een aortocavale fistel.

Aortocaval fistulas are a rare and potentially life-threatening complication of aortic aneurysms. They pose a significant diagnostic challenge due to their aspecific presentation. We describe two cases of patients who were admitted to the emergency room with an unusual presentation. The first patient was a 69-year-old male, with a history of hypertension and hyperlipidemia, who was admitted to our hospital with a painful and swollen left leg. The second patient was a 75-year-old male with a history of coronary artery bypass graft and cholecystectomy who was admitted due to a swollen left leg and dyspnea. We also give a review of the literature regarding the clinical presentation, diagnosis and management of aortocaval fistulas.

Psoas abscess after bacille Calmette-Guérin instillations causing iliac artery contained rupture.

Intravesical administration of bacille Calmette-Guérin (BCG) is considered to be the therapy of choice for treating superficial bladder carcinoma. Created from a live attenuated strain of Mycobacterium bovis, BCG is theoretically unable to cause infections. However, both local and systemic complications due to infection are known to arise, including vascular complications. We describe the case of a patient with a history of BCG instillations presenting with an arterial rupture of his left iliac artery due to an abscess in the iliopsoas muscle.

Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial.

IMPORTANCE: Supervised exercise is recommended as a first-line treatment for intermittent claudication. Combination therapy of endovascular revascularization plus supervised exercise may be more promising but few data comparing the 2 therapies are available. OBJECTIVE: To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 212 patients allocated to either endovascular revascularization plus supervised exercise or supervised exercise only. Data were collected between May 17, 2010, and February 16, 2013, in the Netherlands at 10 sites. Patients were followed up for 12 months and the data were analyzed according to the intention-to-treat principle. INTERVENTIONS: A combination of endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106). MAIN OUTCOMES AND MEASURES: The primary end point was the difference in maximum treadmill walking distance at 12 months between the groups. Secondary end points included treadmill pain-free walking distance, vascular quality of life (VascuQol) score (1 [worst outcome] to 7 [best outcome]), and 36-item Short-Form Health Survey (SF-36) domain scores for physical functioning, physical role functioning, bodily pain, and general health perceptions (0 [severe limitation] to 100 [no limitation]). RESULTS: Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions. CONCLUSIONS AND RELEVANCE: Among patients with intermittent claudication after 1 year of follow-up, a combination therapy of endovascular revascularization followed by supervised exercise resulted in significantly greater improvement in walking distances and health-related quality-of-life scores compared with supervised exercise only. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Endovenous laser ablation versus conventional surgery in the treatment of small saphenous vein incompetence.

INTRODUCTION: In this multicenter, randomized controlled trial, endovenous laser ablation (EVLA) is compared with conventional surgery for the treatment of varicose veins based on incompetence of the small saphenous vein and the saphenopopliteal junction (SPJ). METHODS: In two Dutch hospitals, 189 patients were enrolled and randomized to receive EVLA (810-nm laser) or ligation of the SPJ. End points were success rate measured with duplex ultrasound (6 weeks post-treatment), perioperative pain, quality of life, duration of surgery, difficulty of surgery, complications, cosmetic results, and number of days to resume work and normal activities. Pain was measured on a visual analog scale (VAS). Quality of life was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Euro Qol-5D. The follow-up duration in this article is 6 weeks. RESULTS: One hundred seventy-five patients have been treated and analyzed. One hundred eighteen patients (67%) underwent EVLA, and 57 patients (33%) underwent ligation of the SPJ. The patient characteristics were similar in both groups. In the surgery group, 21% residual incompetence of the SPJ was seen after 6 weeks, compared with 0.9% in the laser group. Both treatment modalities reduced pain after 6 weeks. One week post-treatment, patients in the EVLA group temporarily experienced more pain compared with the surgery group (31 vs 18 on a VAS from 0 to 100). There were no significant differences between the two groups with respect to quality of life. Both treatments did show improvement in quality of life. Also with regard to the cosmetics, there were no differences, aside from the fact that patients rated their scar as more beautiful after EVLA. After EVLA, patients could return to work more quickly. The operation time was longer in the surgery group. After 2 weeks, there were significantly more neurological complications in the surgery group: 18 (31%) vs 16 (17%) patients in the EVLA group. Ten percent of patients in the surgery group developed a surgical site infection vs 0% in the EVLA group. CONCLUSIONS: EVLA provides an excellent alternative to conventional surgery in the treatment of symptomatic varicose veins due to an incompetent small saphenous vein with SPJ. EVLA has a superior immediate success rate, is easier and faster, and has fewer complications.