Colleen M. McCarthy

Predicting Complications following Expander/Implant Breast Reconstruction : An Outcomes Analysis Based on Preoperative Clinical Risk

Background: Complications following postmastectomy reconstruction can cause significant morbidity. The compound effect of individual risk factors on the development of complications following expander/implant reconstruction has not, however, been well delineated. This study evaluated the impact of clinical risk factors to predict complications following postmastectomy expander/implant reconstruction. Methods: From 2003 through 2004, 1170 expander/implant reconstructions were performed at a single center. A prospectively maintained database was reviewed. Variables including age, smoking status, body mass index, history of diabetes, hypertension, chemotherapy and/or radiation, as well as timing and laterality of reconstruction were evaluated. The primary endpoint was the development of a complication; the secondary endpoint was failure of reconstruction. Results: Over the 2 year study period, 1170 expander/implant reconstructions were performed in 884 patients. The odds of developing complications was 2.2 times greater in smokers (p < 0.001) and 2.5 times greater in women over 65 (p = 0.008). Patients who were obese were at nearly two times the odds of having complications (p = 0.02), as were patients with hypertension (p = 0.02). Similarly, the odds of reconstructive failure were five times greater in smokers (p < 0.001). Age was not a significant predictor of reconstructive failure (p = 0.09); yet, failure was nearly seven times greater in obese patients (p < 0.001), and four more times likely in those who were hypertensive (p = 0.005). Conclusions: Smoking, obesity, hypertension, and age over 65 were independent risk factors for perioperative complications following expander/implant breast reconstruction. Smoking, obesity, and hypertension were similarly associated with reconstructive failure. This information can be used to evaluate overall procedural risks and individualize reconstructive options.

A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications.

Background: Multiple prior reports are conflicted regarding the true incidence of complications following implant-based breast reconstruction. A review of a single surgeons extensive experience with tissue expander/implant reconstruction provides the opportunity to critically evaluate outcomes in a uniformly treated patient population. The objective of this study was to analyze the development of early complications in patients following two-stage implant breast reconstruction. Methods: A review of all tissue expander/implant reconstructions performed by a single surgeon over the 12-year period from July of 1992 to June of 2004 was performed. A prospectively maintained database was analyzed with respect to reconstructive and early complication data on 1522 reconstructions in 1221 patients. Early complications were defined as those occurring 12 months or less from initiation of reconstruction. Results: The overall rate of early complications was 5.8 percent; the rate of premature expander removal was 2.7 percent. The most common complication was infection (2.5 percent). The incidence of complications after tissue expander insertion (8.5 percent) was significantly higher than that after the exchange procedure (2.7 percent). The rate of complications was significantly higher in patients with a history of preoperative chest wall irradiation. There was no difference in the incidence of complications in patients who were expanded during chemotherapy and those who were not. Conclusions: Tissue expander/implant reconstruction is a safe, reliable method of reconstruction with minimal early complications. Early complications are more common after expander insertion. Chemotherapy administered during tissue expansion does not increase the rate of complications. The rate of complications, although higher in previously irradiated patients, remains low.

A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part II. An analysis of long-term complications, aesthetic outcomes, and patient satisfaction.

Background: Few reports have critically evaluated long-term outcomes following two-stage implant reconstruction. The objective of this study was to evaluate long-term aesthetic results, late complications, and patient satisfaction following tissue expander/implant breast reconstruction. A single surgeons extensive experience with implant-based reconstruction provides an opportunity to evaluate these results in a uniformly treated patient population. Methods: A total of 1522 tissue expander/implant reconstructions were initiated in 1221 patients from July of 1992 to June of 2004. Data on a cohort of 315 patients (410 reconstructions) with a minimum of 1 year of follow-up were entered into a prospectively maintained outcomes database. Overall aesthetic grade, capsular contracture grade, patient satisfaction, and late complications were prospectively evaluated, and outcome data were recorded on an ongoing basis. Results: Mean follow-up was 36.7 months. Eighty-eight percent of patients had a good to excellent aesthetic result. Laterality of reconstruction (bilateral versus unilateral) and radiation history were significant predictors of overall cosmesis. Aesthetic results were not related to preoperative breast size, implant volume, or body mass index. Pathologic capsular contractures (grade III/IV) developed in 10.4 percent of patients. Four percent of all permanent implants were exchanged for a second prosthesis. Ninety-five percent of patients were satisfied with their reconstruction. Conclusions: Tissue expander/implant reconstruction yields good to excellent long-term aesthetic results in the majority of patients, and overall patient satisfaction remains high. Bilateral reconstructions have higher overall aesthetic grades. Reconstruction may be performed in patients with larger-volume breasts with satisfactory cosmesis. Successful outcomes are possible in patients who receive chest wall irradiation.

Acellular human dermis implantation in 153 immediate two-stage tissue expander breast reconstructions: determining the incidence and significant predictors of complications.

Background: Little information exists on the incidence of complications after acellular human dermis implantation in two-stage tissue expander breast reconstruction. The purpose of this study was to evaluate the incidence of postoperative adverse events and identify significant predictors of complications in acellular human dermis tissue expander breast reconstruction. Methods: This study accrued all patients from January of 2004 through April of 2008 undergoing two-stage immediate tissue expander breast reconstruction using acellular human dermis. A total of 153 expanders were placed. Complications were assessed. Univariate and multivariate logistic regression modeling was performed. Comparison of complication rates using the traditional (non–acellular human dermis) technique from concurrent (2004 to 2008) and consecutive time periods (2001 to 2003) for 2910 and 1170 expanders, respectively, is provided. Results: A total of 153 expanders were implanted in 96 women: 39 unilateral and 57 bilateral. Eleven (7.2 percent) were removed due to infection (n = 5, 3.3 percent), exposure (n = 4, 2.6 percent), or patient preference (n = 2, 1.3 percent). Other complications included cellulitis (3.9 percent), seroma (7.2 percent), hematoma (2.0 percent), mastectomy flap necrosis (4.6 percent), and leak/failed expansion (0.0 percent); 92.8 percent were successfully expanded and exchanged for a permanent implant. Eleven seromas (7.2 percent) were identified; nine underwent aspiration. None of these resulted in infection or reconstructive failure. Univariate analysis revealed age, body mass index, axillary dissection, and postoperative chemotherapy to be associated with reconstructive failure (p < 0.05). Multivariate analysis revealed that age, body mass index, and axillary dissection are independent risk factors for developing complications (p < 0.05). Conclusion: Acellular human dermis is a useful adjunct for intraoperative pocket development in immediate tissue expander reconstruction but can result in an increased risk of complications, in particular, seroma and reconstructive failure.

Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments.

Background: Patient-reported outcomes in cosmetic and reconstructive breast surgery are increasingly important for clinical research endeavors. Traditional surgical outcomes, centered on morbidity and mortality, remain important but are no longer sufficient on their own. Quality of life has become a crucial research topic augmenting traditional concerns focused on complications and survival. Given this, reliable and valid patient questionnaires are essential for aesthetic and reconstructive breast surgeons. Methods: The authors performed a systematic literature review to identify patient-reported outcome measures developed and validated for use in cosmetic and reconstructive breast surgery patients. Qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Results: The authors identified 227 health outcomes questionnaires used in breast surgery studies. After 135 generic instruments, 65 ad hoc instruments, seven oncologic instruments, 11 education questionnaires, and two non-English-language questionnaires were excluded, seven measures remained. Detailed analysis revealed that six of the seven measures had undergone limited development and validation. Only one measure, the Breast-Related Symptoms Questionnaire, demonstrated adequate development and validation in its target population. It had, nevertheless, significant content limitations. Conclusions: Valid, reliable, and responsive instruments to measure patient-reported outcomes in cosmetic and reconstructive breast surgery are lacking. To demonstrate the benefits of aesthetic and reconstructive breast surgery, future research to rigorously develop and validate new cosmetic and reconstructive breast surgery-specific instruments is needed.

A paradigm shift in U.S. breast reconstruction: Part 2. The influence of changing mastectomy patterns on reconstructive rate and method.

Background: The aims of the current study were to (1) measure trends in the type of mastectomy performed, (2) evaluate sociodemographic/hospital characteristics of patients undergoing contralateral prophylactic mastectomy versus unilateral mastectomies, and (3) analyze reconstruction rates and method used following different mastectomy types. Methods: Mastectomies from 1998 to 2008 were analyzed using the Nationwide Inpatient Sample database. Mastectomies (n = 178,603) were classified as either unilateral, contralateral prophylactic, or bilateral prophylactic. Reconstructive procedures were categorized into either implant or autologous. Longitudinal trends were analyzed with Poisson regression and sociodemographic/hospital variables were analyzed with logistic regression. Results: Unilateral mastectomies decreased 2 percent per year, whereas contralateral and bilateral prophylactic mastectomies increased significantly by 15 and 12 percent per year, respectively (p < 0.01). Independent predictors for contralateral prophylactic mastectomy (compared with unilateral mastectomy) were patients younger than 39 years, Caucasian and Hispanic race, private insurance carriers, treated in teaching hospitals, and from South and Midwest regions. Contralateral prophylactic mastectomy is the only group with increased reconstruction rates throughout the study period (p < 0.01). Although implant use increased for all mastectomy types, it remains greater in bilateral and contralateral prophylactic mastectomy. Conclusions: There is increasing use of bilateral mastectomies in the United States, particularly in patients with unilateral cancer. Although implant use has increased for all mastectomy types, they are used most commonly following bilateral and contralateral prophylactic mastectomies. Changing mastectomy patterns are one factor underlying the paradigm shift away from autologous tissue to implant-based reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Measuring Quality of Life in Oncologic Breast Surgery: A Systematic Review of Patient‐Reported Outcome Measures

Abstract:  Multiple randomized trials demonstrate equivalent survival between BCT and mastectomy, but clinical outcomes research must also evaluate patient satisfaction and quality of life. This review analyzes existing patient‐reported outcome (PRO) measures in oncologic breast surgery to assess utility and make recommendations for future research. We performed a systematic literature review to identify PRO measures used in oncologic breast surgery patients. After applying inclusion and exclusion criteria, qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Ten measures underwent development and psychometric evaluation in an oncologic breast surgery population. Five of ten measures (EORTC QLQ BR‐23, FACT‐B, HBIS, BIBCQ, and BREAST‐Q) reported an adequate development and validation process. Three of these 5 measures (EORTC QLQ BR‐23, FACT‐B, HBIS) focused on non‐surgical treatment issues. A fourth instrument (BIBCQ) did not address aesthetic concerns after breast reconstruction. The fifth instrument (BREAST‐Q) was developed for use in patients undergoing mastectomy ± reconstruction, but did not address breast‐conserving therapy. Overall, two key limitations were noted: 1) surgery‐specific issues of breast‐conserving surgery patients were not well represented and 2) measures were largely developed without the aid of newer psychometric methods that may improve their clinical utility. Reliable and valid PRO measures in breast cancer patients exist, but even the best instruments do not address all important surgery‐specific and psychometric issues of oncologic breast surgery patients. Newer psychometric methods would facilitate development of scales for use in individual patient care as well as group level comparisons.

Patient satisfaction and health-related quality of life after autologous tissue breast reconstruction: a prospective analysis of early postoperative outcomes.

For this study, the authors evaluated early psychosocial adjustments and health‐related quality‐of‐life changes after breast reconstruction.

Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants.

At a time when the safety and effectiveness of breast implants remains under close scrutiny, it is important to provide reliable and valid evidence regarding patient outcomes. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life may be the most significant outcome variables when evaluating surgical success. The objective of the current study was to identify predictors of patient satisfaction with breast appearance, including implant type, in a large sample of women who underwent breast reconstruction surgery using implants.

Unilateral postoperative chest wall radiotherapy in bilateral tissue expander/ implant reconstruction patients : A prospective outcomes analysis

Background: Implant reconstruction has a major role to play in breast reconstruction, as some patients neither wish nor are suitable for autogenous reconstruction. The suitability of implant reconstruction in patients who may receive postoperative, adjuvant radiation therapy has not, however, been fully clarified. The purpose of this study was to evaluate complications, capsular contracture, aesthetic outcomes, and patient satisfaction in patients who have undergone bilateral tissue expander/implant reconstruction and unilateral, post exchange, adjuvant radiotherapy. In this study population, the effect of radiation can best be appreciated because the nonirradiated breast acts as a control. Methods: A review of all bilateral tissue expander/implant reconstructions at a single cancer center was undertaken. Twelve patients who underwent bilateral expander/implant reconstruction and unilateral postexchange radiotherapy were eligible for participation. A prospective evaluation of complications, cosmesis, and patient satisfaction was performed. The evaluation of cosmesis and patient satisfaction was executed for 10 of the 12 patients, as two were dead at the time of follow-up. Results: Mean follow-up was 23.5 months (range, 12 to 58.5 years). In 40 percent of patients, there was no discernible difference in capsular contracture between the irradiated and nonirradiated breasts. In 50 percent of patients, the irradiated breast demonstrated increased contracture by a single modified Baker grade. In 10 percent of patients, contracture of the irradiated breast was two modified Baker grades greater than that of the nonirradiated side (grade III versus grade I). Conclusion: For the majority of patients, the degree of capsular contracture was higher on the irradiated side, yet overall symmetry, aesthetic results, and patient satisfaction remained high. These data support the conclusion that immediate, bilateral breast reconstruction using tissue expansion and implants is an acceptable option for the subset of patients who may undergo unilateral, postexchange radiotherapy.