Recurrence Rate and Patient Satisfaction of CO2 Laser Evaporation of Lesions in Patients With Hidradenitis Suppurativa: A Retrospective Study Peter Riis Mikkelsen, MB, Deirde Nathalie Dufour, MD, Kian Zarchi, MD, and Gregor B. E. Jemec, MD, DMSc*
BACKGROUND Hidradenitis suppurativa (HS) is a debilitating disease and is difficult to treat. Validation of surgical techniques is therefore of great importance in the management of HS. Carbon dioxide (CO2) laser evaporation has been shown effective, but larger-scale studies are scarce. OBJECTIVE To determine the recurrence rate, time to recurrence, and factors influencing disease recurrence in skin treated with CO2 laser evaporation, and healing by secondary intention; and patients’ satisfaction with treatment. METHODS Fifty-eight patients treated with CO2 laser evaporation were interviewed regarding recurrence and satisfaction after a mean of 25.7 months. RESULTS Seventeen of 58 (29%) reported recurrence of HS lesions within the borders of the treated areas after a mean of 12.7 months. Obesity was a risk factor for recurrence with a hazard ratio of 4.53. Fifty-five patients (95%) reported some or great improvement, and 91% would recommend the CO2 laser surgery to other HS patients. CONCLUSION This study supports the claim that CO2 laser treatment is an effective modality for recurrent HS lesions in a majority of patients. The authors identified obesity as a risk factor for recurrence. Self-reported satisfaction is high, and only 3 of 58 report no change in the condition. None reported a worsening. The authors have indicated no significant interest with commercial supporters.
H
idradenitis suppurativa (HS) is a chronic, debilitating inflammatory skin disease characterized by painful recurrences, the formation of sinus tracts, and in later stages inflamed fibrotic lesions. The disease characteristically affects the axillae, inframammary areas, and the genitofemoral region.1
Management of HS involves both medical and surgical treatment. Medical treatment of HS consists of topical treatment in mild cases and systemic treatment in more severe cases. Randomized controlled trials suggest efficacy of topical clindamycin,2 systemic tetracycline, infliximab,3 and adalimumab.4 Large cohorts indicate that other drugs such as a combination therapy of clindamycin and rifampicin may be effective.5
Although medical treatment may bring control over inflammatory lesions, it only affects scarring indirectly by preventing disease progression. Surgical treatment is suited for areas with sinus tracts, scarring, and recurrent activity.6 Carbon dioxide (CO2) laser evaporation of lesions has been advocated for the management of HS because of a low recurrence rate and the fact that the sessions can be performed in an office and outpatient setting without the need of postoperative admission to the hospital.7–11 Furthermore, CO2 laser ablation is a tissue-saving technique in which repeated vaporization of affected skin allows the operator to visualize and treat continuously the deeper layers of affected tissue to the level of the subcutis.
*All the authors are affiliated with the Department of Dermatology, Roskilde Hospital, Health Sciences Faculty, University of Copenhagen, Copenhagen, Denmark © 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 Dermatol Surg 2015;41:255–260 DOI: 10.1097/DSS.0000000000000264
·
·
255
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CO2 LASER EVAPORATION OF LESIONS
In this study, the authors report a single-center experience of recurrence rate, time to recurrence, and risk factors influencing recurrence in the operated areas of 58 patients who had undergone their first CO2 laser evaporation from September 2009 to November 2013. The authors also report patient satisfaction with the procedure. Methods This study was designed as a retrospective follow-up study and included 69 consecutive patients who had undergone CO2 laser surgery at the authors’ clinic from September 2009 to November 2013. Method of Surgery All patients were managed as day-cases; they were either immediately discharged to an ordinary outpatient setting or admitted to hospital for less than 24 hours after operations performed in general anesthesia. The procedures were performed in general anesthesia or in local anesthesia using bupivacaine 5 mg/mL mixed 50/50 with lidocaine 20 mg/mL. The CO2 laser used (Lumenis AcuPulse 40 AES-A, Santa Clara, CA) a spot size of 4 mm. The surgery was scanner-assisted in all cases, and energy ranged from 20 to 35 W. All patients were operated as described by Lapins and colleagues.12 After marking the extent of lesions on the surface of the skin, the lesions were evaporated to the level of subcutis removing sinus tracts and all inflamed tissue using visual identification in a controlled manner best comparable with performing “macroscopic Mohs surgery.” In general, hemostasis was ensured by the procedure itself. In a few cases, additional suture was performed using Prolene 3-0 absorbable sutures. The postoperative regime consisted of Mepilex border dressing (Mølnlycke, Gothenburg, Sweden) changed 1 to 2 times a day, and pain management consisted of ibuprofen 400 mg given in combination with paracetamol 1 g 3 or 4 times a day for the first week postoperatively. The size of the defect left by the operations was not recorded, and thus not included for the purposes of this study. Data Patients were contacted by phone or mail and responders were interviewed, by phone or in person. Recently, operated patients who had not reepithelized at
256
the time of interview were excluded from the study (n=1). The patients’ medical charts were reviewed before the interviews, and the information extracted was presented to the patients for verification and evaluation. Interviews were structured to allow easy data extraction. Patients were asked if they had recurrence of HS activity within the borders of the scar, and if that was a case when such recurrence had occurred. The following patient characteristics were collected: age, sex, years with the disease, height, weight at surgery, present weight, and smoking habits. Patients were categorized into 2 groups: above and below 45 years of age. The authors chose this cutoff value because studies have shown that HS tends to improve later in life.13 To determine satisfaction with the procedure, patients were asked to rate their current disease activity in the operated area on a 5-step scale with the following steps: much worse, a little worse, unchanged, some improvement, and great improvement. In addition, the authors asked the patients if they would recommend the surgery to other patients suffering from HS. Statistical Analyses Categorical variables are summarized by frequency and percentage and continuous variables by mean and range. The recurrence-free survival within the borders of the scar was estimated using the Kaplan–Meier method. Disease recurrence was dealt with as an event; otherwise the patients were censored at the time of a new operation in the same anatomical region or at the time of the interview. Censoring was independent and none-informative. A multivariate Cox proportional hazard model was used to identify factors influencing recurrence. Age, sex, obesity, smoking status, and number of areas treated were selected as potentially important predictors. Residuals were used to test the proportional hazard assumption. A significance level of 0.05 was used for all statistical tests. All analyses were performed in the statistical programs SPSS 22.0, or R, version 2.15.2 (R Development Core Team, 2013).
DERMATOLOGIC SURGERY
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
MIKKELSEN ET AL
Results Patients were followed for a mean of 20.6 months postoperatively (range: 1.0–47.0 months). A total of 17 of the 58 patients (29.3%) reported recurrence of HS in the treated area. Patient characteristics are shown in Table 1. Recurrence was reported to occur after a mean of 12.2 months (range: 1.0–33.3 months). The Kaplan–Meier curve (Figure 1) shows recurrencefree survival for the patients; results are summarized in Table 2. Hazard ratios were calculated for obesity, smoking status, age, sex and number of areas treated. As seen in Table 3, obesity remains a statistically significant (p < .011) risk factor with a hazard ratio of 4.53 (1.41– 14.56). Smoking status has a high hazard ratio of 4.54 (0.956–21.56) but is not significant (p < .057) after adjusting for age, sex, body mass index (BMI), and number of locations. Patients were generally satisfied with the postoperative results, 55 of 58 patients (95%) reporting a small (n = 11) or great improvement (n = 44). Only 3 of 58 (5%) reported unchanged status, all of whom had recurrence in the treated area. None reported worsening of the condition. Table 3 shows the distribution of reported satisfaction and recurrence status. Patients were interviewed after a mean of 25.7 months (2.9–54.0 months, SD, 11.2). Of the patients, 53 of 58 (91%) reported that they would recommend the procedure to others with similar
Figure 1. The Kaplan–Meier curve showing recurrence for all patients. The x-axis is the time in years, and y-axis is the cumulative disease-free survival.
disease. Of these, 15 (28.3%) had experienced recurrence. Four patients would not recommend the procedure: 2 experienced recurrence postoperatively, 1 had contractures of the scar, and 1 had an episode of bleeding from the wound on the first postoperative day. Discussion The authors find that 29% of the first-time CO2 laser– treated lesions recur within the borders of the scar within 12.2 months on average, and that obesity is a significant risk factor for recurrence (hazard ratio, 4.53; 95% confidence interval: 1.41–14.56). Previous studies on HS lesions treated with CO2 laser have shown a very low risk of recurrence from 0% (0 of 6)7 to 14.4% (1 of 7).10,11 Table 4 shows a summary of the results of previous studies within the area.
TABLE 1. Patient Characteristics Patients, n Sex
58 48/10 (women/men)
BMI, kg/m2
29.8 (6.0 SD)
Age at operation, mean, years
37.8 (21–54)
Smokers, n (%)
48 (82.8)
Years of disease, mean Patients with a positive family history of HS, n (%)
18.1 (4–39) 37 (63.8)
Number of areas treated, mean
1.7 (1–4)
The number of areas treated is the number of topical areas treated in the first operation, that is, axils, groin etc.
In the study by Lapins and colleagues,10 the 4 cases (4 of 34 = 11.7%) of recurrence happened within 6 months, but the mean follow-up time was 34.5 months. Compared with the 17 cases (17 of 58 = 29.3%) that recurred in this study after a mean of TABLE 2. Patients Percentage With RecurrenceFree Survival by Years After 1 year, %
80.53
After 2 years, % After 3 years, %
73.23 52.32
41:2:FEBRUARY 2015
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
257
CO2 LASER EVAPORATION OF LESIONS
of patients. The results of the routine use of CO2 laser evaporation studied here seem to be comparable with these reported surgical outcomes.
TABLE 3. Hazard Ratios for Recurrence, Calculated by Cox-Regression
Variable
Adjusted Hazard Ration (95% CI)
p
In a study of the deroofing technique by van der Zee and colleagues,16 investigators found recurrence in 15 of 88 lesions (17%). The study population of van der Zee’s study, however, is quite different from the population of this study. Patients in the study by van der Zee are all classified as Hurley Stage 1 or 2. Additionally, smoking status is not recorded and the mean BMI is considerably lower at 26.8 kg/m2 compared with a mean of 29.8 kg/m2 in this study.
Sex Male
Reference
Female
0.57 (0.15–2.231)
.418
Age, years
BACKGROUND Hidradenitis suppurativa (HS) is a debilitating disease and is difficult to treat. Validation of surgical techniques is therefore of great importance in the management of HS. Carbon dioxide (CO2) laser evaporation has been shown effective, but larger-scale studies are scarce. OBJECTIVE To determine the recurrence rate, time to recurrence, and factors influencing disease recurrence in skin treated with CO2 laser evaporation, and healing by secondary intention; and patients’ satisfaction with treatment. METHODS Fifty-eight patients treated with CO2 laser evaporation were interviewed regarding recurrence and satisfaction after a mean of 25.7 months. RESULTS Seventeen of 58 (29%) reported recurrence of HS lesions within the borders of the treated areas after a mean of 12.7 months. Obesity was a risk factor for recurrence with a hazard ratio of 4.53. Fifty-five patients (95%) reported some or great improvement, and 91% would recommend the CO2 laser surgery to other HS patients. CONCLUSION This study supports the claim that CO2 laser treatment is an effective modality for recurrent HS lesions in a majority of patients. The authors identified obesity as a risk factor for recurrence. Self-reported satisfaction is high, and only 3 of 58 report no change in the condition. None reported a worsening. The authors have indicated no significant interest with commercial supporters.
H
idradenitis suppurativa (HS) is a chronic, debilitating inflammatory skin disease characterized by painful recurrences, the formation of sinus tracts, and in later stages inflamed fibrotic lesions. The disease characteristically affects the axillae, inframammary areas, and the genitofemoral region.1
Management of HS involves both medical and surgical treatment. Medical treatment of HS consists of topical treatment in mild cases and systemic treatment in more severe cases. Randomized controlled trials suggest efficacy of topical clindamycin,2 systemic tetracycline, infliximab,3 and adalimumab.4 Large cohorts indicate that other drugs such as a combination therapy of clindamycin and rifampicin may be effective.5
Although medical treatment may bring control over inflammatory lesions, it only affects scarring indirectly by preventing disease progression. Surgical treatment is suited for areas with sinus tracts, scarring, and recurrent activity.6 Carbon dioxide (CO2) laser evaporation of lesions has been advocated for the management of HS because of a low recurrence rate and the fact that the sessions can be performed in an office and outpatient setting without the need of postoperative admission to the hospital.7–11 Furthermore, CO2 laser ablation is a tissue-saving technique in which repeated vaporization of affected skin allows the operator to visualize and treat continuously the deeper layers of affected tissue to the level of the subcutis.
*All the authors are affiliated with the Department of Dermatology, Roskilde Hospital, Health Sciences Faculty, University of Copenhagen, Copenhagen, Denmark © 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 Dermatol Surg 2015;41:255–260 DOI: 10.1097/DSS.0000000000000264
·
·
255
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CO2 LASER EVAPORATION OF LESIONS
In this study, the authors report a single-center experience of recurrence rate, time to recurrence, and risk factors influencing recurrence in the operated areas of 58 patients who had undergone their first CO2 laser evaporation from September 2009 to November 2013. The authors also report patient satisfaction with the procedure. Methods This study was designed as a retrospective follow-up study and included 69 consecutive patients who had undergone CO2 laser surgery at the authors’ clinic from September 2009 to November 2013. Method of Surgery All patients were managed as day-cases; they were either immediately discharged to an ordinary outpatient setting or admitted to hospital for less than 24 hours after operations performed in general anesthesia. The procedures were performed in general anesthesia or in local anesthesia using bupivacaine 5 mg/mL mixed 50/50 with lidocaine 20 mg/mL. The CO2 laser used (Lumenis AcuPulse 40 AES-A, Santa Clara, CA) a spot size of 4 mm. The surgery was scanner-assisted in all cases, and energy ranged from 20 to 35 W. All patients were operated as described by Lapins and colleagues.12 After marking the extent of lesions on the surface of the skin, the lesions were evaporated to the level of subcutis removing sinus tracts and all inflamed tissue using visual identification in a controlled manner best comparable with performing “macroscopic Mohs surgery.” In general, hemostasis was ensured by the procedure itself. In a few cases, additional suture was performed using Prolene 3-0 absorbable sutures. The postoperative regime consisted of Mepilex border dressing (Mølnlycke, Gothenburg, Sweden) changed 1 to 2 times a day, and pain management consisted of ibuprofen 400 mg given in combination with paracetamol 1 g 3 or 4 times a day for the first week postoperatively. The size of the defect left by the operations was not recorded, and thus not included for the purposes of this study. Data Patients were contacted by phone or mail and responders were interviewed, by phone or in person. Recently, operated patients who had not reepithelized at
256
the time of interview were excluded from the study (n=1). The patients’ medical charts were reviewed before the interviews, and the information extracted was presented to the patients for verification and evaluation. Interviews were structured to allow easy data extraction. Patients were asked if they had recurrence of HS activity within the borders of the scar, and if that was a case when such recurrence had occurred. The following patient characteristics were collected: age, sex, years with the disease, height, weight at surgery, present weight, and smoking habits. Patients were categorized into 2 groups: above and below 45 years of age. The authors chose this cutoff value because studies have shown that HS tends to improve later in life.13 To determine satisfaction with the procedure, patients were asked to rate their current disease activity in the operated area on a 5-step scale with the following steps: much worse, a little worse, unchanged, some improvement, and great improvement. In addition, the authors asked the patients if they would recommend the surgery to other patients suffering from HS. Statistical Analyses Categorical variables are summarized by frequency and percentage and continuous variables by mean and range. The recurrence-free survival within the borders of the scar was estimated using the Kaplan–Meier method. Disease recurrence was dealt with as an event; otherwise the patients were censored at the time of a new operation in the same anatomical region or at the time of the interview. Censoring was independent and none-informative. A multivariate Cox proportional hazard model was used to identify factors influencing recurrence. Age, sex, obesity, smoking status, and number of areas treated were selected as potentially important predictors. Residuals were used to test the proportional hazard assumption. A significance level of 0.05 was used for all statistical tests. All analyses were performed in the statistical programs SPSS 22.0, or R, version 2.15.2 (R Development Core Team, 2013).
DERMATOLOGIC SURGERY
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
MIKKELSEN ET AL
Results Patients were followed for a mean of 20.6 months postoperatively (range: 1.0–47.0 months). A total of 17 of the 58 patients (29.3%) reported recurrence of HS in the treated area. Patient characteristics are shown in Table 1. Recurrence was reported to occur after a mean of 12.2 months (range: 1.0–33.3 months). The Kaplan–Meier curve (Figure 1) shows recurrencefree survival for the patients; results are summarized in Table 2. Hazard ratios were calculated for obesity, smoking status, age, sex and number of areas treated. As seen in Table 3, obesity remains a statistically significant (p < .011) risk factor with a hazard ratio of 4.53 (1.41– 14.56). Smoking status has a high hazard ratio of 4.54 (0.956–21.56) but is not significant (p < .057) after adjusting for age, sex, body mass index (BMI), and number of locations. Patients were generally satisfied with the postoperative results, 55 of 58 patients (95%) reporting a small (n = 11) or great improvement (n = 44). Only 3 of 58 (5%) reported unchanged status, all of whom had recurrence in the treated area. None reported worsening of the condition. Table 3 shows the distribution of reported satisfaction and recurrence status. Patients were interviewed after a mean of 25.7 months (2.9–54.0 months, SD, 11.2). Of the patients, 53 of 58 (91%) reported that they would recommend the procedure to others with similar
Figure 1. The Kaplan–Meier curve showing recurrence for all patients. The x-axis is the time in years, and y-axis is the cumulative disease-free survival.
disease. Of these, 15 (28.3%) had experienced recurrence. Four patients would not recommend the procedure: 2 experienced recurrence postoperatively, 1 had contractures of the scar, and 1 had an episode of bleeding from the wound on the first postoperative day. Discussion The authors find that 29% of the first-time CO2 laser– treated lesions recur within the borders of the scar within 12.2 months on average, and that obesity is a significant risk factor for recurrence (hazard ratio, 4.53; 95% confidence interval: 1.41–14.56). Previous studies on HS lesions treated with CO2 laser have shown a very low risk of recurrence from 0% (0 of 6)7 to 14.4% (1 of 7).10,11 Table 4 shows a summary of the results of previous studies within the area.
TABLE 1. Patient Characteristics Patients, n Sex
58 48/10 (women/men)
BMI, kg/m2
29.8 (6.0 SD)
Age at operation, mean, years
37.8 (21–54)
Smokers, n (%)
48 (82.8)
Years of disease, mean Patients with a positive family history of HS, n (%)
18.1 (4–39) 37 (63.8)
Number of areas treated, mean
1.7 (1–4)
The number of areas treated is the number of topical areas treated in the first operation, that is, axils, groin etc.
In the study by Lapins and colleagues,10 the 4 cases (4 of 34 = 11.7%) of recurrence happened within 6 months, but the mean follow-up time was 34.5 months. Compared with the 17 cases (17 of 58 = 29.3%) that recurred in this study after a mean of TABLE 2. Patients Percentage With RecurrenceFree Survival by Years After 1 year, %
80.53
After 2 years, % After 3 years, %
73.23 52.32
41:2:FEBRUARY 2015
© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
257
CO2 LASER EVAPORATION OF LESIONS
of patients. The results of the routine use of CO2 laser evaporation studied here seem to be comparable with these reported surgical outcomes.
TABLE 3. Hazard Ratios for Recurrence, Calculated by Cox-Regression
Variable
Adjusted Hazard Ration (95% CI)
p
In a study of the deroofing technique by van der Zee and colleagues,16 investigators found recurrence in 15 of 88 lesions (17%). The study population of van der Zee’s study, however, is quite different from the population of this study. Patients in the study by van der Zee are all classified as Hurley Stage 1 or 2. Additionally, smoking status is not recorded and the mean BMI is considerably lower at 26.8 kg/m2 compared with a mean of 29.8 kg/m2 in this study.
Sex Male
Reference
Female
0.57 (0.15–2.231)
.418
Age, years
