Breast reconstruction has an important role BREAST. A Two-Year Prospective Analysis of Trunk Function in TRAM Breast Reconstructions

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1 BREAST A Two-Year Prospective Analysis of Trunk Function in TRAM Breast Reconstructions Amy K. Alderman, M.D. William M. Kuzon, Jr., M.D., Ph.D. Edwin G. Wilkins, M.D. Ann Arbor, Mich. Background: Functional outcomes in breast reconstruction are important quality measures and aid in patients decision-making process. To address the concerns of abdominal wall morbidity with transverse rectus abdominis musculocutaneous (TRAM) flap reconstructions, the authors prospectively evaluated the long-term effects of postmastectomy breast reconstruction on trunk function using objective clinical measures. Methods: Using a multicenter prospective cohort design, they recruited women undergoing first-time immediate or delayed breast reconstructions from 12 centers and 23 plastic surgeons. Trunk functional data, objectively measured with Cybex machines, for patients with an expander/implant, pedicle TRAM, and free TRAM reconstructions were evaluated preoperatively and at postoperative years 1 and 2 in 183 patients. The effects of procedure type, timing, and laterality on trunk peak torque and range of motion were analyzed using linear regression. Results: At 2 years postoperatively, procedure type, timing, and laterality did not significantly affect the range of motion for trunk flexion and extension. Peak torque for trunk flexion at year 2 was significantly decreased in patients with TRAM compared with expander/implant reconstructions (p 0.05), with a 6 to 19 percent decrease in flexion peak torque. However, no significant difference in flexion peak torque was found between patients with free and pedicle TRAM reconstructions. Conclusions: The authors found that (1) breast cancer patients with TRAM reconstructions had a less than 20 percent long-term deficit in trunk flexion peak torque and (2) there was no significant difference in trunk function between patients receiving pedicle and free TRAM reconstructions. (Plast. Reconstr. Surg. 117: 2131, 2006.) From the Section of Plastic Surgery, Department of Surgery, The University of Michigan Medical Center; and Veterans Affairs Center for Practice Management and Outcomes Research, Ann Arbor Veterans Affairs Health Care System. Received for publication April 28, 2005; revised May 23, Presented at the 82nd Annual Meeting of the American Association of Plastic Surgeons, in Baltimore, Maryland, May 4 to 7, Copyright 2006 by the American Society of Plastic Surgeons DOI: /01.prs a Breast reconstruction has an important role in women s health, especially as the incidence of breast cancer in the United States (217,440 cases in 2004) continues to rise. 1 Outcome data on these reconstructive procedures are important for surgeons and patients decision-making process. Although both expander/ implant and autogenous tissue reconstructions are associated with high levels of patient satisfaction and improved quality of life, transverse rectus abdominis musculocutaneous (TRAM) procedures generally outperform expander/ implant reconstructions in most patient satisfaction and aesthetic categories. 2 6 However, many patients and surgeons are concerned about the abdominal wall morbidity of TRAM procedures. 7,8 Previous functional outcomes studies found mixed results, with data on TRAM procedures ranging from a6to23percent deficit in trunk function. 9,10 However, these studies are limited in study design and time to follow-up, which warrants further investigation using a cohort trial with 2-year postoperative data. These data are especially important now, as some surgeons are performing more technically complex procedures, such as muscle-sparing free TRAMs and perforator flaps, to limit the surgical insult on the abdominal wall. Therefore, the purpose of our study was to use objective clinical measures to describe and compare the long-term outcomes of trunk function

2 Plastic and Reconstructive Surgery June 2006 in the postmastectomy population. Our hypotheses were that (1) patients with a TRAM (both free and pedicle) reconstruction have substantial long-term functional deficits in trunk flexion and range of motion compared with patients with an expander/implant and (2) patients with pedicle TRAM reconstructions have significantly worse long-term trunk flexion and range of motion than patients with free TRAM procedures. PATIENTS AND METHODS Study Population From 1994 to 2000, patients were evaluated as part of the Michigan Breast Reconstruction Outcome Study, a prospective multicenter cohort study of mastectomy reconstruction patients. The study population included first-time, immediate or delayed, unilateral or bilateral reconstructions with expander/implants, pedicle TRAM, or free TRAM techniques. Data from 23 plastic surgeons across 12 medical centers in Louisiana, Michigan, Pennsylvania, and Ontario, Canada, were included in the study. Of the 460 patients enrolled in the study, 64 patients withdrew, yielding a dropout rate of 14 percent. We excluded patients with latissimus dorsi or double pedicle TRAM procedures because of the small sample size for those procedures. We also excluded patients with combined reconstructions, such as having both a TRAM and an expander/implant or both a free and pedicle TRAM procedure. Objective outcome data on trunk isokinetic peak torque and range of motion were complete for 183 patients at postoperative year 2. The mean ages of patients in the pedicle TRAM, free TRAM, and expander/implant groups were 52, 51 and 53 years, respectively. Data Collection Trunk peak torque and range of motion data were collected preoperatively and at postoperative years 1 and 2. The isokinetic testing was performed using a Cybex machine, which measured peak torque (feet per pounds) at two different speeds. The slower speed, 30 degrees per second, assisted in patient education of the activity. The higher speed, 90 degrees per second, assisted in determining functional ability because activities of daily living generally occur at faster speeds. Data on both speeds were provided for comparison. The expander/implant population represented our control group for abdominal wall function. Data Analysis Paired t test analyses were performed for the bivariate analyses, and linear regression models controlled for possible confounding. The primary independent variable of interest was procedure type. For the three procedure types, two dummy variables were created to indicate the pedicle and free TRAM flap groups. The dummy variables assessed the effect of the particular procedure type on trunk function relative to the expander/implant group. The models included the independent variables that were thought to be associated with functional outcomes, including preoperative trunk function, laterality (unilateral or bilateral), timing (immediate or delayed), and patient age. Trunk function and age were set as continuous variables, and the others were used as categorical variables. RESULTS Table 1 summarizes the study population by the type and timing of reconstruction at postoperative year 2. Pedicle TRAM reconstructions outnumbered both expander/implant and free TRAM procedures nearly 2:1, and the majority of women had an immediate rather than a delayed procedure. Most delayed reconstructions were performed with a pedicle TRAM flap, and patients with expander/implant reconstructions had the largest proportion of bilateral procedures. Tables 2 and 3 display the isokinetic peak torque for trunk flexion and extension by proce- Table 1. Study Population by Procedure Type, Timing, and Laterality at Postoperative Year 2 Expander/Implant [No. (%)] Pedicle TRAM [No. (%)] Free TRAM [No. (%)] Timing Immediate 37 (77.1) 52 (55.9) 30 (71.4) Delayed 7 (14.6) 38 (40.9) 11 (26.2) Immediate and delayed 4 (8.3) 3 (3.2) 1 (2.4) Total Laterality Unilateral 31 (64.6) 76 (81.7) 36 (85.7) Bilateral 17 (35.4) 17 (18.3) 6 (14.3) Total TRAM, transverse rectus abdominis musculocutaneous. 2132

3 Volume 117, Number 7 Trunk Function in Breast Reconstruction Table 2. Two-Year Postoperative Isokinetic Trunk Function (feet/pound) by Type of Postmastectomy Reconstruction at 30 Degrees per Second Mean Trunk Flexion (ft/lb) Torque Mean Trunk Extension (ft/lb) Torque Pre Post SD CI Pre Post SD CI Expander/implant Unilateral to to 8.9 Bilateral to to 14.8 Free TRAM Unilateral to to 11.5 Bilateral to to 16.8 Pedicle TRAM Unilateral to to 13.9 Bilateral to to 20.5 CI, 95 percent confidence interval; TRAM, transverse rectus abdominis musculocutaneous. dure type at 30 and 90 degrees per second. For trunk extension, the bivariate and multivariate analyses showed no significant effect by procedure type. Figures 1 and 2 graphically represent the changes in trunk flexion for unilateral procedures at the slow and fast speeds, respectively. Postoperative trunk flexion for unilateral procedures was very similar at the two different speeds, except for a slightly greater decrease in mean torque trunk flexion for free TRAMs at the faster speed (6 percent decrease at 30 degrees per second compared with 14 percent decrease at 90 degrees per second). Figures 3 and 4 display mean torque trunk flexion for bilateral procedures at both speeds. Trunk flexion for bilateral procedures was similar at both the slow and fast speeds, although the pedicle TRAM group had a larger decline in function at the slow speed ( 19 percent) compared with performance at the faster speed ( 12 percent). These functional differences between patients with free and pedicle TRAM procedures were not statistically significant. Figures 1 through 4 also display the relative similarity in function between the pedicle and free TRAM groups. For unilateral procedures at the slower speed, only a 5 percent relative difference existed between the pedicle TRAM patients (with an 11 percent decline) and the free TRAM patients (who had a 6 percent decline). At the faster speed, patients with a pedicle compared with a free TRAM had an 11 percent compared with 14 percent decline in peak torque. Bivariate analyses showed no statistical significance in these differences. For bilateral procedures, both pedicle and free TRAMs had a 19 percent decline in flexion at the slower speed. At the faster speed, pedicle TRAMs had a 12 percent decline compared with the 18 percent decline in the free TRAM group, a difference that was not statistically significant. The regression models for trunk flexion at postoperative year 2 for both Cybex speeds are shown in Tables 4 through 7. These models evaluated the effect of procedure type on flexion peak torque while controlling for potential confounders such as Table 3. Two-Year Postoperative Isokinetic Trunk Function (feet/pound) by Type of Postmastectomy Reconstruction at 90 Degrees per Second Mean Trunk Flexion (ft/lb) Torque Mean Trunk Extension (ft/lb) Torque Pre Post SD CI Pre Post SD CI Expander/implant Unilateral to to 11.8 Bilateral to to 21.4 Free TRAM Unilateral to to 2.3 Bilateral to to 17.4 Pedicle TRAM Unilateral to to 6.3 Bilateral to to 21.5 CI, 95 percent confidence interval; TRAM, transverse rectus abdominis musculocutaneous. 2133

4 Plastic and Reconstructive Surgery June 2006 Fig. 1. Trunk flexion (peak torque) for unilateral breast reconstructions at 30 degrees per second. Fig. 2. Trunk flexion (peak torque) for unilateral breast reconstructions at 90 degrees per second. Fig. 3. Trunk flexion (peak torque) for bilateral breast reconstructions at 30 degrees per second. age, timing of reconstruction, laterality, and preoperative trunk function. Similar regression models on trunk flexion and extension peak torque by procedure type for postoperative year 1 versus postoperative year 2 showed no significant differences in outcomes at either the slow or fast speeds. Tables 4 and 5 display the regression models comparing the effects of TRAM (free and pedicle) procedures on trunk flexion peak torque compared with expander/implant reconstructions at 30 degrees per second and 90 degrees per second, respectively. In both models, TRAM flaps had a significantly lower trunk flexion peak torque at postoperative year 2 (p 0.01 for TRAM reconstructions at both speeds). Tables 6 and 7 describe the regression models, comparing the effect of free versus pedicle TRAM procedures 2134

5 Volume 117, Number 7 Trunk Function in Breast Reconstruction Fig. 4. Trunk flexion (peak torque) for bilateral breast reconstructions at 90 degrees per second. Table 4. Linear Regression of Trunk Flexion (30 degrees/second) at Postoperative Year 2 Comparing TRAM Procedures to Expander/Implant Reconstructions (n 183) Independent Variable Coefficient SE p CI Expander/implant TRAM (free and pedicle) to 9.02 Age to 0.35 Delayed reconstruction to 3.87 Preoperative trunk flexion (ft/lb) at 30 degrees/sec to 0.75 Unilateral procedures to TRAM, transverse rectus abdominis musculocutaneous; SE, standard error; CI, 95 percent confidence interval. on trunk peak flexion at 30 degrees per second and 90 degrees per second, respectively. The type of TRAM procedure did not have a significant effect on trunk flexion peak torque. Table 8 displays the data on trunk range of motion at postoperative year 2 for all three procedures. In both the bivariate and multivariate regression models, procedure type had no significant effect on trunk range of motion. DISCUSSION For the past 20 years, free and pedicle TRAM flaps have been reliable techniques for creating natural-appearing breast reconstructions However, patients and physicians are concerned about the abdominal wall morbidity associated with these procedures and, as a result, are turning to more complex reconstructions, such as perforator flaps. However, perforator flaps have limitations, such as the potential increased risk of flap loss and fat necrosis. 15,16 In addition, the current reimbursement environment makes perforator flap reconstructions financially difficult for many surgeons to accommodate in their practice. Surgeons and patients are facing a challenging reconstructive algorithm that teeters between a tech- Table 5. Linear Regression of Trunk Flexion (90 degrees/second) at Postoperative Year 2 Comparing TRAM to Expander/Implant Reconstructions (n 183) Independent Variable Coefficient SE p CI Expander/implant TRAM (free and pedicle) to 5.23 Age to 0.23 Delayed reconstruction to 6.73 Preoperative trunk flexion (ft/lb) at 90 degrees/sec to 0.72 Unilateral procedures to 9.03 TRAM, transverse rectus abdominis musculocutaneous; SE, standard error; CI, 95 percent confidence interval. 2135

6 Plastic and Reconstructive Surgery June 2006 Table 6. Linear Regression of Trunk Flexion (30 degrees/second) at Postoperative Year 2 Comparing Free and Pedicle TRAM Procedures (n 183) Independent Variable Coefficient SE p CI Free TRAM Pedicle TRAM to 5.39 Age to 0.37 Delayed reconstruction to 4.79 Preoperative trunk flexion (ft/lb) at 30 degrees/sec to 0.78 Unilateral procedures to TRAM, transverse rectus abdominis musculocutaneous; SE, standard error; CI, 95 percent confidence interval. nically more difficult operation with a potentially higher rate of flap complications and a more predictable operation with higher abdominal wall morbidity. Outcome data, such as patient satisfaction, complication rates, and functional outcomes, are crucial for both patients and surgeons to navigate this complex decision analysis for reconstruction. Our goal with this project was to provide objective outcome data on abdominal wall function that can aid in this multifaceted decisionmaking process. Abdominal wall function after a traditional TRAM reconstruction has been previously evaluated using subjective and objective measures in the 6-month to 1-year postoperative period. The data of Suominen et al. 9 suggested a 6 11 percent deficit in trunk flexion torque with free TRAM breast reconstructions at postoperative year 1. They found no significant deficits in either trunk extension or activities of daily living. The data of Dulin et al. 17 on pedicle TRAM reconstructions at postoperative year 1 demonstrated a significant decrease in trunk flexion from preoperative levels in the bilateral pedicle TRAM group ( ft/lb to ft/lb). The unilateral group trended toward a lower functional status from preoperative levels, but this did not reach statistical significance, most likely because of sample size limitations. The study of Kind et al. 10 found no procedural difference in trunk function between pedicle and free TRAM breast reconstructions. Trunk flexion peak torques in patients with pedicle and free TRAM reconstructions were 77 9 percent and 82 7 percent of preoperative levels at postoperative year 1. These studies had some limitations, such as being single-surgeon or single-center studies without control groups. However, our findings at postoperative year 2 were consistent with those of the previous work in this area. Between 6 and 19 percent of patients had a persistent deficit in abdominal wall trunk flexion, but no significant difference was observed between patients with free and pedicle TRAM reconstructions. Objective data on abdominal wall function in patients with perforator flap reconstructions are limited. Hamdi et al. 18 evaluated sit-up ability in patients with perforator flap reconstructions at 3 and 6 months postoperatively. At 3 months, 95 percent of women were able to return to their preoperative sit-up activity, and 100 percent of patients were able to perform this at 6 months postoperatively. Unfortunately, a TRAM comparison group was not included in the study design, and sit-up ability can be an unreliable objective measure of trunk function. 19 Blondeel et al. 20 evaluated abdominal wall function in patients with deep inferior epigastric perforator (DIEP) flaps compared with free TRAM reconstructions. The TRAM group had significantly lower trunk flexion torque compared with the DIEP group, although the study did not control for potential confounding variables, such as preoperative trunk function and patient age. Table 7. Linear Regression of Trunk Flexion (90 Degrees per Second) at Postoperative Year 2 Comparing Free and Pedicle TRAM Procedures (n 183) Independent Variable Coefficient SE p CI Free TRAM Pedicle TRAM to Age to 0.23 Delayed reconstruction to 6.10 Preoperative trunk flexion (ft/lb) at 30 degrees/sec to 0.69 Unilateral procedures to TRAM, transverse rectus abdominis musculocutaneous; SE, standard error; CI, 95 percent confidence interval. 2136

7 Volume 117, Number 7 Trunk Function in Breast Reconstruction Table 8. Two-Year Postoperative Trunk Range of Motion by Type of Postmastectomy Reconstruction Trunk Flexion (degrees) Trunk Extension (degrees) Pre Post SD CI Pre Post SD CI Implant Unilateral to to 5.2 Bilateral to to 8.5 Free TRAM Unilateral to to 5.0 Bilateral to to 9.2 Pedicle TRAM Unilateral to to 0.1 Bilateral to to 13.4 CI, 95 percent confidence interval; TRAM, transverse rectus abdominis musculocutaneous. Our study had several limitations. We noted a 14 percent dropout rate, and these patients may have been significantly different across multiple variables compared with our study population. Our study design was not randomized, which opens the possibility of variables influencing the results that are not controlled for in the regression models. In addition, 2-year follow-up may not have been long enough to adequately assess long-term postoperative results with abdominal function. In regard to our study s free TRAM reconstructions, data are not available on whether the surgeon used a musclesparing technique or sacrificed the entire muscle. We also do not have a perforator flap comparison group, which would have been the optimal study design to compare the functional outcomes of patients with these types of reconstructive procedures. In summary, the elegance of perforator flap reconstructions is undeniable. However, the feasibility of these procedures for mainstream plastic surgery is questionable because of the necessity for microsurgical expertise and the financial constraints in the current reimbursement environment. Based on objective measures of physical functioning, conventional TRAM reconstructions weaken the abdominal wall, and our long-term data suggest a6to19 percent decrease in trunk flexion peak torque for both free and pedicle TRAM techniques. However, the effects of these deficits on patients day-to-day quality of life remain unclear. The effect of implant and TRAM breast reconstructions on subjective measures of physical functioning, such as activities of daily living assessments, will be reported in a future article. Meanwhile, it remains debatable whether the functional sequelae of pedicle and free TRAM harvest provide sufficient rationale for abandonment of these procedures in favor of the more technically challenging perforator flaps. Amy K. Alderman, M.D. Plastic and Reconstructive Surgery University of Michigan 2130 Taubman Center 1500 East Medical Center Drive Ann Arbor, Mich aalder@umich.edu REFERENCES 1. SEER Web site. Available at SEER.html. Accessed April 1, Alderman, A. K., Wilkins, E., Lowery, J., et al. Determinants of patient satisfaction in post-mastectomy breast reconstruction. Plast. Reconstr. Surg. 106: 769, McCraw, J. B., Horton, C. E., Gorssman, J. A. I., Kaplan, I., and McMellin, A. An early appraisal of the methods of tissue expansion and the transverse rectus abdominis musculocutaneous flap in reconstruction of the breast following mastectomy. Ann. Plast. Surg. 18: 93, Noda, S., Eberlein, T. J., and Eriksson, E. Breast reconstruction. Cancer Suppl. 74: 376, Brandberg, Y., Malm, M., and Blomqvist, L. A prospective and randomized study, SVEA, comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast. Reconstr. Surg. 105: 66, Kroll, S. S., and Baldwin, B. A comparison of outcomes using three different methods of breast reconstruction. Plast. Reconstr. Surg. 90: 455, Kroll, S. S., and Marchi, M. Comparison of strategies for preventing abdominal-wall weakness after TRAM flap breast reconstruction. Plast. Reconstr. Surg. 89: 1045, Lejour, M., and Dome, M. Abdominal wall function after rectus abdominis transfer. Plast. Reconstr. Surg. 87: 1054, Suominen, S., Asko-Seljavaara, S., Kinnunen, J., et al. Abdominal wall competence after free transverse rectus abdominis musculocutaneous flap harvest: A prospective study. Ann. Plast. Surg. 39: 229, Kind, G. M., Rademaker, A. W., and Mustoe, T. A. Abdominal-wall recovery following TRAM flap: A functional outcome study. Plast. Reconstr. Surg. 99: 417, Eberlein, T. J., Crespo, L. D., Smith, B. L., et al. Prospective evaluation of immediate reconstruction after mastectomy. Ann. Plast. Surg. 218: 29,

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