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ORIGINAL ARTICLES |
From the Departments of Plastic Surgery (KYL, FRJ, ML, DBD), Health Evaluation Sciences (JG), and Surgery (MMM), University of Virginia Health Sciences System, Charlottesville, Virginia.
Correspondence: Address correspondence and reprint requests to: Kant Y. Lin, MD, Associate Professor, Department of Plastic Surgery, Box 800376, University of Virginia Health Sciences Center, Charlottesville, VA 22908; Fax: 804-924-1333; E-mail: kyl5s@ virginia.edu.
| ABSTRACT |
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Methods: A retrospective study was performed on a consecutive series of 123 breast reconstructions in 98 patients, performed by one of two plastic surgeons, in a university setting over a 5-year period, for all surgical outcomes. Specifically, wound-healing complications, infections, and reoperations leading to the potential delay of subsequent chemotherapy or radiotherapy were recorded, and possible risk factors leading to these were sought.
Results: Three presurgical risk factors were found to have a statistically significant influence on the development of complications following breast reconstruction. These were: (1) increasing obesity, defined by the body mass index, (2) an active or recent (<5 year) history of cigarette smoking, and (3) a history of previous radiation exposure. Odds ratios were used to describe the magnitude of the effect of each factor for the development of complications. An ordinal regression analysis was used to create a nomogram based on this information that can be used to calculate any individual patients presurgical risk for developing major complications following breast reconstruction, based on the presence of these factors.
Conclusions: It is possible, based on the presence of specific presurgical risk factors, to predict the probability of developing major complications following breast reconstruction. This information can be useful to the referring physician and plastic surgeon alike in determining which patients are the best candidates for breast reconstruction and which type of reconstruction would be best suited for each individual patient.
Key Words: Breast reconstruction Risk factors Obesity Cigarette smoking Radiotherapy
| INTRODUCTION |
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The purpose of this study was to ascertain: (1) whether there are specific physical or lifestyle factors that predispose patients to major postreconstruction complications, and (2) whether there are any differences between the various surgical techniques of breast reconstruction in terms of the likelihood to develop complications.
| MATERIALS AND METHODS |
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Data Analysis
Descriptive statistics were given as mean (standard deviation), or as the percent of patients having the characteristic. Comparisons for continuous variables (such as degree of obesity or BMI, and age) were given as F tests; categorical variables (such as history of smoking, previous radiation exposure, associated medical conditions, and incidence of major complications) were given as
2 tests. All descriptive tests were unadjusted for possible confounding or effect-modifying covariables. Ordinal logistic regression was used to determine the effect of explanatory covariates on the level of complication (such as major, minor, none) in a patient. Odds ratios were used to describe the magnitude of the effect of an explanatory variable on the complication level.
| RESULTS |
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All reconstructions utilized one of three surgical techniques, which included: 70 pedicled transverse rectus abdominus myocutaneous (TRAM) flaps, 14 free tissue transfer TRAM flaps and 39 tissue expander/implants. Free tissue transfer TRAM flaps were only performed in the last 3 years of the study period. The mean ages of each group were: 47.7 years (range, 2862) for the pedicled TRAMs, 43.2 years (range, 3754) for the free tissue TRAMs, and 46.9 years (range, 2972) for the expander/implant group. The major complication rate for all groups combined was determined to be 26 of 123 or 21.1%. Between groups, the pedicled TRAMs had 15 of 70 complications for a rate of 21.4%, the free tissue TRAMs had 0 of 14 for a rate of 0%, and the expander/implants had 11 of 39 complications for a rate of 23.1% (Table 1).
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A total of 10 patients (10 of 123 for a rate of 8.1%) had prolonged convalescent periods greater than 6 weeks due to wound complications, potentially leading to a delay in the initiation of adjuvant chemotherapy. All 10 underwent a reoperation as the result of their wound complications. Eight patients were in the pedicled TRAM group, none in the free tissue TRAMs, and two in the expander/implant group. The length of delay averaged 20 days, with a range of 1460 days. Not all patients who underwent a reoperation, however, had delayed wound healing beyond 6 weeks.
Various attributes in either physical characteristics, past medical history, or lifestyles of the patients were considered when looking for risk factors for the development of postoperative complications. The body mass index (BMI) was calculated for each patient as kilograms/meters2, and obesity was defined as a BMI > 28. The average BMI for all patients was 24.59 kg/m2 and for each group: the pedicled TRAMs was 24.8 kg/m2, free tissue TRAMs was 24.9 kg/m2, and expander/implants was 25.3 kg/m2.
Twenty out of 98 patients (20.4%) had a current or recent (within 5 years of surgery) history of cigarette smoking. Between groups, the pedicled TRAMs had 11 of 57 smokers (18.6%), the free tissue TRAMs had 3 of 11 smokers (27.3%), and the expander/implants had 6 of 31 smokers (19%). A total of 11 patients in all groups (11 of 98 or 11.2%) had a history of prior radiation treatments to the breast area: 7 in the pedicled TRAMs, 0 in the free tissue TRAMs, and 4 in the expander/implant group. Only three patients in the entire series had serious concomitant medical conditions, all with insulin-dependent diabetes mellitus. All three of these patients underwent expansion/implant reconstruction.
Data Analysis
Results of the F test and
2 analysis failed to reveal any significant differences between the patients grouped according to the three types of reconstructive techniques, based on age, BMI, smoking history, previous radiation history, and the incidence of major complications (Table 1). The number of patients in the free tissue transfer TRAM group were markedly less than in the other two surgical groups, however, in part due to the shorter period of time over which this procedure was performed. Due to this difference in numbers, our biostatistician considered any analysis of risk factors using this group as too deficient in power for meaningful statistical significance. Therefore, only the pedicled TRAM and expander/implant groups were used in the ordinal logistical regression analysis for the effect of explanatory covariates on complications in the patients. This model demonstrated a significant effect of the BMI (P = .006) and a smoking history (P = .03) for the development of major complications following reconstruction.
2 analysis demonstrated a significant effect (P = .05) of previous radiation exposure for the development of major complications in the expander/implant group only, an effect not seen in the pedicled TRAM group. No conclusions could be reached regarding the effect of concomitant medical illnesses, because the number of patients with other medical illnesses in this study was too small to statistically analyze.
Based on this information, a nomogram was created to visually represent the results of the statistical model. Points were assigned based on a smoking history and degree of obesity that, when totaled, could be converted into a predicted probability of developing any complication as well as major complications following breast reconstruction (Fig. 1). A hypothetical illustration of its usage is as follows: a patient with an active smoking history and a BMI of 26, would be assigned a point value of 7 for the smoking and a point value of 8 for obesity, based on the topmost scale in the nomogram. When totaled, this would yield a final point value of 15. This value is then extrapolated from the total points scale onto the two bottom scales of the nomogram to determine a probability of developing complications, which in this case is 87% for any complication and 55% for a major complication with delay of adjuvant therapy.
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| DISCUSSION |
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Gradual acknowledgment on the part of the oncologic team regarding the importance of breast reconstruction has also revolutionized breast cancer care. Performed at first on a judiciously delayed basis and only after a prolonged cancer-free period was demonstrated, reconstruction is now more oftentimes than not performed immediately following the initial mastectomy. Earlier studies have documented that immediate reconstruction can be done safely in patients, with no adverse effects in terms of early cancer recurrence or with the incidence of distant metastases.8,9 However, because the administration of postsurgical chemotherapy has become more commonplace, concerns have grown over whether immediate postoperative complications following reconstruction might delay the initiation of adjuvant chemotherapy and radiotherapy. A study by Yule, et.al.10 looked at chemotherapy following immediate breast reconstruction in 46 consecutive patients with tissue expanders and implants, but instead of looking at the possible delay in starting the chemotherapy, they addressed the issue of whether the chemotherapy itself caused complications with the reconstruction. Deutsch, et al.11 reviewed a series of 31 patients who underwent neoadjuvant chemotherapy, followed by mastectomy and immediate reconstruction with either pedicled or free tissue transfer TRAM flaps. Fifty-five percent of the patients had postoperative complications, but only 6% had delay in resuming their chemotherapy following surgery. Among the smokers, 71% had a postoperative complication and, of the delayed patients, 30% were smokers. Although suggestive of a causal relationship, their numbers were too small to detect a statistical difference between smokers and nonsmokers for the risk of developing complications leading to a delay in chemotherapy.
Obesity has been documented by several previous studies to pose a significant risk for developing complications following reconstruction. Berrino, et.al.12 used the BMI and classified their study group into Type II (20% overweight) and Type III (40% overweight) patients. They found that both groups had a higher incidence of postoperative complications than nonobese patients, although no differences between the two obese groups were noted. Kroll and Netscher13 used a height/weight index and stratified their patients into mild, moderate, and markedly obese. They were able to demonstrate a correlation between increasing obesity, as defined by the three subsets, with an increased complication rate following TRAM breast reconstruction. Paige et al.14 defined obesity as more than 25% over ideal body weight and noted that their patients with this characteristic had a higher incidence of complications over nonobese patients. All three of these studies limited the obese classification to either a single category or to a noncontinuous subgroup, whereas the present study evaluated obesity as a continuous variable. Furthermore, the time frame within which the complications occurred was not addressed in any of these other studies.
Smoking has also been well documented by several previous clinical studies to have an adverse effect on breast reconstruction outcomes, specifically when musculocutaneous flaps are utilized.15,16 The results of the present study regarding smoking are in complete agreement with those. Our results corroborated the study by Watterson et al.16 which demonstrated a significant risk with smoking (P < .002) for the development of complications following TRAM flap breast reconstruction in 556 patients.
Our study also agreed with their results regarding the risk of obesity (P < .02), which was defined as more than 25% over ideal body weight, but differed when it came to chest wall irradiation where we saw a risk only with implant reconstruction, whereas they saw a risk in autogenous tissue reconstruction.
Kroll13 stratified the smokers in their study into current and ex-smokers (those who had quit at least 12 months prior to the surgery), both of whom showed a higher risk than patients who had never smoked in the paSt. We included any patient who had quit smoking within 5 years of the surgery in the smoking group in our analysis, because studies have documented that the risk of cardiovascular disease does not normalize until at least 5 years from the cessation of smoking.17
Our overall rates of complications with both the TRAM flaps and expander/implants correlated well with other larger series in the literature.14,18 Paige et al.14 was the only other study that we came across that did discuss the effects of having more than one risk factor present at the same time, but our study was able to quantitate the influence of the risk factors on complications either individually or in combination. Our study also differed in that we offer a method to preoperatively predict the probability of developing postoperative complications based on the presence of either one or both risk factors.
Finally, in agreement with other studies, our data supported the hypothesis that previous radiation exposure constituted an additional risk factor for complications specifically in the tissue expander/implant group.19,20 There is a growing body of evidence that the changes in the skin secondary to radiation exposure create significant problems when subsequent tissue expansion is attempted, which results in very high complication rates. Not surprisingly, myocutaneous flap reconstruction does not appear to be affected by previous radiotherapy, mainly because nonirradiated distant skin is brought into the area of reconstruction as part of the flap, thus obviating the need to use the already damaged irradiated skin of the chest wall.
Differences between using the pedicled and free-tissue transfer musculocutaneous flaps relate to the microcirculation of the tissue being used as the breast substitute. In a free-tissue microvascular transfer of the TRAM flap, the dominant vascular pedicle is anastomosed to the donor vessels, thus ensuring maximum vascularity to the flap. Conversely, the pedicled myocutaneous flap relies on the nondominant vessel and is thus more prone to incremental ischemia, but rarely does one encounter a catastrophic thrombotic failure of the microanastomosis, leading to a complete loss of the flap as can be seen in free tissue transfers. The use of tissue expanders and subsequent implant prostheses has the disadvantage of utilizing a foreign body, thus always being prone to infection or extrusion as well as device failure. This study demonstrated that the differences inherent between the pedicled TRAM technique and the expander/implant technique did not pose a potential risk sufficient enough to warrant the use of one technique over another in specific patients. Unfortunately, the number of patients in which the free tissue transfer TRAM group was utilized in the present study was insufficient for any meaningful statistical analysis. Despite the smaller numbers however, this group appeared especially promising with zero complications in a population with a greater percentage of a known adverse risk factor, namely a smoking history. Follow-up studies with larger numbers will be necessary before this trend can be confirmed. The ability to quantifiably identify patients preoperatively who are at higher risk for developing complications following mastectomy and reconstruction, particularly as it relates to the timing for beginning postsurgical adjuvant treatments, will enable the treating physicians to choose a more appropriate treatment method to fit the circumstances of any individual patient.
Received for publication January 11, 2001. Accepted for publication April 13, 2001.
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