Venous ulcers are the last state of the chronic venous insufficiency which treatment is long, expensive, and disappointing. The affected patients are usually treated by compressive therapy of the legs and wound dressings of different kinds [
The association of venous ulcers and saphenous vein reflux is well established, and therefore we encourage a rapid surgical decision on these patients focused on the hemodynamic control rather than the treatment of the ulcer alone [
We report our early experience with crossectomy and foam sclerotherapy (CAFE) of the great saphenous vein in patients with saphenous vein reflux and venous ulceration.
Between September 2008 and January 2010, 35 patients with active venous leg ulcer were recruited for the study. Twenty-nine accomplished the follow-up period.
Group I consisted of 21 patients (23 limbs), 6 males, and 15 females, with an average age of 58.9 years (range: 36–86). Of the 21 patients, 17 had primary CVI and 4 had postthrombotic limbs.
Group II had 8 patients (10 limbs), 2 males and 8 females, with an average age of 58.5 years (range: 43–71). Three patients had post-thrombotic limbs and 5 had primary CVI (Table
Patients.
Group I | Group II | |
---|---|---|
Patients | 21 | 8 |
Limbs | 23 | 10 |
Primary CVI (Patients) | 17 | 5 |
Secondary CVI (Patients) | 4 | 3 |
Mean age | 59 | 58.5 |
A complete vascular examination was performed in order to rule out significant arterial disease and ABI > 0.9 was found in all the patients; venous ultrasound was done in order to confirm greater or lesser saphenous vein reflux and exclude any occlusive thrombus in the deep or perforator systems. The Doppler duplex scan color evaluations were done with Sonosite MicroMaxx Ultrasound System (Sonosite, Inc. Bothell, WA, USA), 5–10 MHz electronic linear array probe, in standing position in order to find reflux, which was considered positive if it was 1 second or longer, and the saphenous vein diameter was 4 mm or more at the saphenofemoral junction. Then the patient was examined in prone position to exclude the aforementioned thrombus. Size of the ulcer was measured by the use of a metrical strip. These observations were registered in the record of each patient and they were conducted to elective surgery.
In group I the surgical procedure consisted in crossectomy of the affected saphenous vein and the distal saphenous vein was canalized with a 6 F silicon Nelaton urethral tube until the knee level and slowly filled with foam; meanwhile the tube was withdrawn; the foam was built with 6 cc of polidocanol 1% (Polydosclerol, Sigvaris, Sig Med, 16 Parkway North Deerfield, IL, USA) foamed with 18 cc of air (3 : 1) using Tessari’s technique [
(a) Foam preparation. (b) Foam injection in the great saphenous vein.
Spasm of the great saphenous vein and tributaries.
In Group II all the 8 patients have a crossectomy and removal of the saphenous vein between the groin and the ankle. The medium stretch elastic bandage compression was changed daily. Both, the patients and their relatives were instructed about the way to change and to put the elastic bandages from the forefoot to the above knee area of the leg. The first change was done by us.
Clinical and ultrasound follow-up was performed 7 and 14 days after the surgery (Figure
Obliteration of the great saphenous vein.
Ulcer healed.
All data were expressed in terms of means and standard deviation from the mean. Fischer’s test was used to compare the two groups at the end points: ulcer healing and healing rate.
The follow-up ranged from 2 to 17 months. At the time of procedure the area of ulceration ranged from 0.5 to 204 cm2 (mean: 41.9 cm2) in group I. In group II the follow-up ranged from 2 to 15 months and the size of ulceration ranged from 2 to 30 cm2 (mean: 12.71 cm2).
During follow-up there were eight cases of incomplete healing of the ulcer, four in Group I (19.04%)—in one of them an incompetent Cockett perforating vein was showed and later treated by ultrasound guided sclerotherapy—and four in Group II (40%)
In the Group I ulcer healing occurred in average time of 56.6 days, ranged from 17 to 160 during the follow after the procedure, and the rate of healing was of 19 of 23 limbs (82.6%). None of these patients have had recurrence in the follow up period. In group II ulcer healing occurred in average time of 39 days, ranged from 15 to 89, and the rate of healing was of 6 of 10 limbs. None had recurrence. Mean ulcer healing speed was 0.38 cm/day in group I and 0.13 cm/day in group II
Skin infection after surgery.
Table
Characteristics and evolution of group I patients.
Patient | Age | Gender | Leg | Comorbidities | Ulcer area | Evolution time (months) | Date of surgery | Date of healing | Days | Rate cm/day |
---|---|---|---|---|---|---|---|---|---|---|
1 | 58 | F | Left | SAH | 12 | 16 | 29/11/2009 | 06/01/2010 | 45 | 0.266 |
2 | 61 | F | Left | N | 20 | 360 | 24/10/2009 | Not healed | ||
3 | 71 | F | Left | N | 4 | 12 | 25/09/2009 | 12/11/2009 | 48 | 0.083 |
4 | 62 | F | Right | N | 16 | 6 | 24/09/2009 | 28/10/2009 | 38 | 0.421 |
5 | 64 | F | Left | SAH | 12 | 15 | 13/09/2009 | 07/10/2009 | 34 | 0.352 |
6 | 63 | F | Left | SAH, DVT | 180 | 60 | 03/09/2009 | Not healed | ||
7 | 53 | M | Left | DVT | 2 | 72 | 30/08/2009 | 27/09/2010 | 28 | 0.071 |
8 | 42 | F | Right | N | 1.5 | 6 | 20/08/2009 | 27/01/2010 | 160 | 0.009 |
9 | 86 | F | Right | SAH | 7 | 9 | 12/06/2009 | 02/07/2009 | 20 | 0.35 |
10 | 58 | F | Left | Ovarian cancer | 56 | 29 | 01/06/2009 | 18/08/2009 | 78 | 0.717 |
11 | 72 | F | Right | SAH | 34 | 420 | 31/05/2009 | 29/07/2009 | 59 | 0.576 |
12 | 47 | F | Bilat. | N | 33 | 18 | 29/05/2009 | 22/07/2009 | 74 | 0.445 |
13 | 40 | M | Right | DVT | 7 | 48 | 20/04/2009 | 20/05/2009 | 30 | 0.233 |
14 | 62 | M | Bilat. | N | 15 | 120 | 29/03/2009 | 15/04/2009 | 17 | 0.882 |
15 | 38 | M | Right | SAH, DVT | 0.5 | 30 | 19/03/2009 | 21/05/2009 | 33 | 0.015 |
16 | 61 | F | Right | Pott | 180 | 60 | 16/03/2009 | Not healed | ||
17 | 72 | F | Right | SAH | 12 | 12 | 02/03/2009 | 06/09/2009 | 137 | 0.087 |
18 | 69 | M | Right | Barrett | 204 | 17 | 02/03/2009 | Not healed | ||
19 | 68 | F | Right | N | 4 | 34 | 22/02/2009 | 11/03/2009 | 17 | 0.235 |
20 | 54 | M | Right | Diabetes | 70 | 60 | 19/02/2009 | 17/06/2009 | 126 | 0.555 |
21 | 36 | F | Left | N | 16 | 45 | 16/09/2008 | 15/10/2008 | 29 | 0.551 |
| ||||||||||
Mean | 58.9 | 42.19 | 69 | 56.6 | 0.38 |
N: none. SAH: systemic arterial hypertension. DVT: deep vein thrombosis. Pott: Pott disease. Barrett: Barrett esophagus. Bilat: bilateral.
Table
Characteristics and evolution of group II patients.
Patient | Age | Gender | Leg | Comorbidities | Ulcer area | Evolution time (months) | Date of surgery | Date of healing | Days | Rate cm/day |
---|---|---|---|---|---|---|---|---|---|---|
1 | 61 | F | Right | SAH | 10 | 60 | 26/07/2009 | 24/11/2009 | 89 | 0.112 |
2 | 71 | M | Right | SAH, CHF | 8 | 60 | 31/07/2009 | 30/09/2009 | 60 | 0.133 |
3 | 52 | F | Bilat. | 4,5 | 8 | 29/11/2009 | 12/01/2010 | 14 | 0.071 | |
4 | 56 | M | Bilat. | DVT | 30 | 36 | 25/10/2008 | Not healed | ||
5 | 69 | F | Left | SAH | 15 | 24 | 11/02/2009 | Not healed | ||
6 | 52 | F | Left | DVT | 4 | 36 | 31/01/2010 | 17/02/2010 | 17 | 0.235 |
7 | 43 | F | Left | 2 | 12 | 12/06/2009 | 27/06/2009 | 15 | 0.133 | |
8 | 64 | F | Left | DVT | 20 | 6 | 20/08/2009 | Not healed | ||
| ||||||||||
Mean | 58.5 | 12.714 | 30.25 | 39 | 0.136 |
N: none. SAH: systemic arterial hypertension. DVT: deep vein thrombosis. Pott: Pott disease. Barrett: Barrett esophagus. Bilat: Bilateral.
Venous ulcer is the latest state of venous disease with high social and healthcare cost and with deterioration of quality of life [
Our goal is the development of a definitive treatment, with minimal chances of complications and recurrences and a low cost. This technique must eradicate the reflux from the main incompetent vein just in its origin and along the incompetent saphenous trunk and its main incompetent tributaries, it must be minimally invasive, with proven effectiveness not affected by the vein size or tortuosity, and finally it must have wide availability and low cost.
Sclerotherapy is widely used as a cosmetic practice to treat spider veins to treat venous malformations [
Foam has the extra advantages of being visible under ultrasound, painless, easy to handle, and is not expensive. The rate of occlusion of veins with this technique is very high [
Stability of the foam is an issue and it depends on the tensoactive properties of the product and Polidocanol is a detergent with good foam stability.
Under a CEAP 6 patient, as we have shown in this study, CAFE of the great saphenous vein in this group of patients made it possible to reach the healing of more than 80% of the ulcers without complications and faster than in the stripping of the saphenous vein group.