Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins.

BACKGROUND: This trial compared outcomes after foam sclerotherapy in patients wearing compression bandaging for 24 h or 5 days after treatment. METHODS: Consecutive patients with primary uncomplicated varicose veins were randomized after foam sclerotherapy treatment. The primary endpoint was 6-week Aberdeen Varicose Vein Severity Score (AVVSS) and Burford pain score. RESULTS: Some 124 legs were randomized, 61 to 24 h and 63 to 5 days of bandaging. Target vein occlusion rates at 6-week duplex imaging were 90 and 89 per cent respectively (P = 0.842). There was no significant difference in phlebitis after 2 weeks (P = 0.445) or skin discoloration after 6 weeks (46 versus 40 per cent; P = 0.546). There was no significant difference in the change in AVVSS from baseline to 2 weeks (-0.29 versus -0.80; P = 0.717) or to 6 weeks (-5.89 versus -5.14; 95 per cent confidence interval (c.i.) for the difference -3.29 to 1.80; P = 0.563), or in change in Burford pain score from baseline to 2 weeks (-9.04 versus -2.80; P = 0.248) or to 6 weeks (-17.32 versus -8.46; 95 per cent c.i. for the difference -19.06 to 1.33; P = 0.088), or in change in Short Form 36 score from baseline to 6 weeks (2.02 versus 1.74; P = 0.903). CONCLUSION: There was no advantage to compression bandaging for more than 24 h when thromboembolus deterrent stockings were worn for the remainder of 14 days. REGISTRATION NUMBER: NCT00991497 (http://www.clinicaltrials.gov).

Randomised clinical trial of foam sclerotherapy for patients with a venous leg ulcer.

OBJECTIVES: To assess whether routine use of foam sclerotherapy, in addition to four-layer compression bandaging, could speed up the healing of venous ulcers. DESIGN: Randomised controlled trial involving patients recruited from a nurse-led leg ulcer clinic. A total of 315 new patients were assessed, and eleven patients were identified from follow-up clinics. METHODS: Inclusion criteria were: patients with an active venous leg ulcer, in the presence of superficial truncal venous incompetence and without total deep venous incompetence on duplex imaging. Patients were randomised to four-layer compression bandages alone (control) or with additional foam sclerotherapy to incompetent superficial truncal veins. The primary endpoint was ulcer healing 24 weeks after randomisation. RESULTS: It was only possible to recruit 40 patients who were suitable for analysis: 22 control, 18 additional foam sclerotherapy. There was no complication from the foam treatment and at six months the target vein was occluded in 9 of 11 evaluable patients that had foam. One patient died before 24 weeks from an unrelated cause. At 24 weeks, 17 of 20 (85% - 1 died) in the control group and 12 of 13 (92%) patients with additional foam sclerotherapy had ulcer healing (P=0.72, log rank testing). CONCLUSION: This trial failed to recruit sufficient patients for formal comparison, but foam sclerotherapy was feasible as an adjunct to compression therapy for venous ulceration. TRIAL REGISTRATION: Eudra CT 2005-001551-38.

Mid term results of ultrasound guided foam sclerotherapy for complicated and uncomplicated varicose veins.

OBJECTIVE: The aim was to describe the results of starting a foam sclerotherapy service, focussing on patients with complicated venous disease. METHODS: Consecutive patients undergoing ultrasound-guided foam sclerotherapy for truncal varicose veins underwent clinical and hand-held Doppler assessment at 2 weeks and venous duplex imaging at 6 months. RESULTS: One hundred and eighty-five truncal veins were treated in 165 patients. A high proportion of veins were complicated (109 CEAP classes 4-6, 76 CEAP 1-3). Ninety-one percent (168) had a single treatment session. After 2 weeks, ninety-three percent (136/147) of the truncal veins appeared occluded on hand-held Doppler examination. Ten percent (15/147) of patients had remaining visible varicosities in the lower leg. After six months, the truncal vein remained occluded in 74% (68/92), was partially occluded in 10% (9/92) and fully patent in 16% (15/92). There was no significant difference in occlusion rates between: primary (45/60-75%) and recurrent (23/32-72%) veins; CEAP 2-3 (22/30-73%) and CEAP 4-6 (46/62-74%) veins; veins with diameter <7 mm (29/38-76%) or > or =7 mm (13/23-57%). No patient had evidence of deep vein thrombosis, though nine (10%) had new segmental deep venous reflux compared with pre-treatment scans. CONCLUSION: Foam sclerotherapy was equally effective for complicated and uncomplicated varicose veins.

Feasibility and clinical decision-making with 3D echocardiography in routine practice.

OBJECTIVE: To assess the feasibility and potential impact of routine three-dimensional (3D) echocardiographic assessment of left ventricular (LV) ejection fraction and volumes on clinical decision-making. METHODS: Patients referred to three hospital-based echocardiography laboratories underwent 2D echocardiography (2DE) and 3D echocardiography (3DE). Feasibility was assessed in a group of 168 unselected patients and decision-making assessed within an expanded group of 220 patients. The time for acquisition and measurement was obtained. Feasibility was defined by ability to measure LV parameters. The potential of 3DE to alter clinical decisions based on 2DE was evaluated by the ability to identify four clinically relevant measurement thresholds: (1) LV end-systolic volume (LVESV) >50 ml/m(2) (indication for surgery in regurgitant valve disease); (2) LVESV >30 ml/m(2) (prognosis after infarction); (3) LV ejection fraction (LVEF) <35% (indication for implantable defibrillator); and (4) LVEF <40% (indication for heart failure treatment). RESULTS: 3DE was technically feasible in 83% of unselected patients. The additional time for 3D acquisition and measurement was available in 184 patients and was 5.4 (SD 2.0) minutes. The use of 3DE changed categorisation in between 6-11% of patients. Within threshold categories, 3D reallocated 17.5% (11/63) of patients with LVEF <35%, 16.1% (13/81) for LVEF <40%, 12.4% (13/105) for LVESV >30 ml/m(2) and 8.5% (5/59) for LVESV >50 ml/m(2). Most of the impact of 3D was within 10 ml/m(2) of selected volume thresholds (>or=75%) and 10% of EF thresholds (>80%). CONCLUSION: Measurement of LV volumes and EF by 3DE is clinically feasible and has the potential to significantly alter clinical decision-making.

The use of foam sclerotherapy for varicose veins: a survey of the members of the Vascular Society of Great Britain and Ireland.

OBJECTIVES: The aim was to explore the current experience and practice of vascular surgeons in the United Kingdom and Ireland regarding foam sclerotherapy for varicose veins. METHOD: A postal questionnaire was sent to 609 members of the Vascular Society of Great Britain and Ireland. RESULTS: There were 281 responses (47%). Seventy surgeons (25%) used foam sclerotherapy. Most use it selectively; few (29%) offer it to all patients. It was more likely to be used for recurrent varices (71%), in older patients (61%) and for smaller non-saphenous varices (67%). The majority of surgeons (69%) used sodium tetradecyl sulphate and up to a maximum of 10-12 ml of foam. The majority used ultrasound guidance (95%), leg elevation (69%) and direct pressure over the saphenofemoral or saphenopopliteal junction during injection (63%). Eighty per cent used compression bandaging after treatment, usually for 7 days (44%). Ninety percent advised compression stockings, usually Class II (64%) for 14 days (39%). Serious complications were few, but eleven surgeons had seen a deep vein thrombosis, two had seen a patient with a stroke and one a transient ischaemic attack. CONCLUSION: Foam sclerotherapy was used by a quarter of surgeons who replied to the survey. Aspects of technique varied considerably and studies to determine optimal techniques are needed. Serious complications with the technique were rare.

Late results of mesh wound closure after elective open aortic aneurysm repair.

INTRODUCTION: Incisional hernia is a common late complication after abdominal aortic aneurysm (AAA) repair. We examined the outcome after prophylactic placement of a pre-peritoneal polypropylene mesh during abdominal closure in consecutive patients having elective AAA repair. REPORT: At least 30 months after surgery, 28 patients underwent clinical and ultrasound examination of their surgical wound for incisional hernias. Only one patient had a hernia in the original surgical scar. No patients had late mesh-related wound problems. DISCUSSION: Pre-peritoneal polypropylene mesh placement is a simple, safe and effective method to decrease the incidence of incisional hernia after AAA repair.

Comparison of four automated hematology analyzers.

OBJECTIVE: To compare four automated hematology analyzers for efficiency and sensitivity. DESIGN: Four automated hematology analyzers were compared in a side by side study: Bayer ADVIA 120 (Bayer Diagnostic Division, Tarrytown, NY), Beckman Coulter GEN S (Beckman Coulter, Brea, CA), Abbott CELL DYN 3500 and CELL DYN 4000 (Abbott Diagnostics, Santa Clara, CA). 164 specimens were analyzed for cell counts, indices, and the automated WBC differential (DLC). Tallies were kept of all interventions, defined as any parameter necessitating examination of a stained blood smear by a clinical laboratory scientist. A 400-cell manual differential was performed on each specimen and used as the reference to prepare truth tables for each type of WBC. PATIENTS: Specimens comprised regular runs from this tertiary care teaching hospital. These included inpatients, outpatients, and oncology patients, including bone marrow transplant patients. MAIN OUTCOME MEASURES: Results from the truth tables were used for calculating sensitivity and efficiency for each analyzer. Each DLC parameter was analyzed for variance using the one-way ANOVA test. RESULTS: No intervention was required for 103 of 164 specimens for the CELL DYN 3500; the ADVIA gave 70 reportable DLCs without intervention, the GEN S provided 91 and the CELL DYN 4000 resulted in 117 of 164 DLCs without intervention. Agreement or efficiency was 65% for the CELL DYN 3500, 41% for the ADVLA, 58% for the GEN S, and 79% for the CELL DYN 4000. Sensitivity was 67% for the CELL DYN 3500, 86% for the ADVIA, 76% for the GEN S, and 71% for the CELL DYN 4000. Probability of significant variation was as follows for each parameter: % neutrophil 0.8747, % lymphocyte 0.8830, % monocyte 0.0296, % eosinophil 0.7903, and % basophil <.0001. CONCLUSION: The analyzers tested were acceptable for routine laboratory work. Selection would depend on individual need with respect to sensitivity and efficiency. The clinical significance of disagreement between the DLC and the manual differential remains to be determined.