Peter G. Cordeiro

Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.

Background: Measuring patient-reported outcomes has become increasingly important in cosmetic and reconstructive breast surgery. The objective of this study was to develop a new patient-reported outcome measure to assess the unique outcomes of breast surgery patients. Methods: Patient interviews, focus groups, expert panels, and a literature review were used to develop a conceptual framework and a list of questionnaire items. Three procedure-specific questionnaires (augmentation, reduction, and reconstruction) were developed and cognitive debriefing interviews used to pilot each questionnaire. Revised questionnaires were field tested with 1950 women at five centers in the United States and Canada (response rate, 72 percent); 491 patients also completed a test-retest questionnaire. Rasch measurement methods were used to construct scales, and traditional psychometric analyses, following currently recommended procedures and criteria, were performed to allow for comparison with existing measures. Results: The conceptual framework included six domains: satisfaction with breasts, overall outcome, and process of care, and psychosocial, physical, and sexual well-being. Independent scales were constructed for these domains. This new patient-reported outcome measure “system” (the BREAST-Q) contains three modules (augmentation, reconstruction, and reduction), each with a preoperative and postoperative version. Each scale fulfilled Rasch and traditional psychometric criteria (including person separation index 0.76 to 0.95; Cronbach’s alpha 0.81 to 0.96; and test-retest reproducibility 0.73 to 0.96). Conclusions: The BREAST-Q can be used to study the impact and effectiveness of breast surgery from the patient’s perspective. By quantifying satisfaction and important aspects of health-related quality of life, the BREAST-Q has the potential to support advocacy, quality metrics, and an evidence-based approach to surgical practice.

Reconstruction of the mandible with osseous free flaps: a 10-year experience with 150 consecutive patients.

Osseous free flaps have become the preferred method for reconstructing segmental mandibular defects. Of 457 head and neck free flaps, 150 osseous mandible reconstructions were performed over a 10-year period. This experience was retrospectively reviewed to establish an approach to osseous free flap mandible reconstruction. There were 94 male and 56 female patients (mean age, 50 years; range 3 to 79 years); 43 percent had hemimandibular defects, and the rest had central, lateral, or a combination defect. Donor sites included the fibula (90 percent), radius (4 percent), scapula (4 percent), and ilium (2 percent). Rigid fixation (up to five osteotomy sites) was used in 98 percent of patients. Aesthetic and functional results were evaluated a minimum of 6 months postoperatively. The free flap success rate was 100 percent, and bony union was achieved in 97 percent of the osteotomy sites. Osseointegrated dental implants were placed in 20 patients. A return to an unrestricted diet was achieved in 45 percent of patients; 45 percent returned to a soft diet, and 5 percent were on a liquid diet. Five percent of patients required enteral feeding to maintain weight. Speech was assessed as normal (36 percent), near normal (27 percent), intelligible (28 percent), or unintelligible (9 percent). Aesthetic outcome was judged as excellent (32 percent), good (27 percent), fair (27 percent), or poor (14 percent). This study demonstrates a very high success rate, with good-to-excellent functional and aesthetic results using osseous free flaps for primary mandible reconstruction. The fibula donor site should be the first choice for most cases, particularly those with anterior or large bony defects requiring multiple osteotomies. Use of alternative donor sites (i.e., radius and scapula) is best reserved for cases with large soft-tissue and minimal bone requirements. The ilium is recommended only when other options are unavailable. Thoughtful flap selection and design should supplant the need for multiple, simultaneous free flaps and vein grafting in most cases.

Factors associated with complications in microvascular reconstruction of head and neck defects.

The use of microvascular free tissue transfer has allowed the reconstruction of increasingly complex defects in higher risk patients after head and neck cancer resections. However, the combination of these factors also gives rise to a higher risk for the development of complications. This study was performed to establish the pretreatment factors associated with complication development after microvascular free tissue transfer for the reconstruction of defects resulting from head and neck cancer ablations, with particular attention to the role of comorbid conditions. A retrospective cohort study was conducted including 200 consecutive microvascular free tissue transfers performed for the reconstruction of surgical defects in the head and neck region at a single tertiary care institution. Comorbidity severity was assessed using the Charlson comorbidity index, a novel approach to comorbid staging in this setting. The flap survival rate was 98 percent. Complications developed in 56 cases (28 percent), with multiple complications occurring in 21 of these cases (10.5 percent). Univariate analysis revealed that prior radiation treatment (p = 0.03), anesthesia time over 10 hours (0.05), and advanced Charlson comorbidity grade (0.002) were associated with an increased risk for the development of complications. However, only the presence of advanced Charlson grade proved significant after multivariate analysis (odds ratio 3.9; 95 percent CI = 1.5 to 10.1). In addition, increasing Charlson grade (p = 0.003) and age over 70 years (p = 0.04) correlated with increasing complication severity. Systemic complications occurred in 28 patients (14 percent), with advanced Charlson grade being the only significant factor associated with the development of complications after controlling for confounding factors (odds ratio 3.8; 95 percent CI = 1.5 to 9.7). In patients over 70 years of age, increasing operative time also impacted on the development of systemic complications (p = 0.002), especially in patients with advanced Charlson grades (0.01). Recipient site complications occurred in 30 patients (15 percent), with history of prior radiation therapy being the only factor associated with increased risk by multivariate analysis (odds ratio 2.5; 95 percent CI = 1.1 to 5.7). No factors predicted the development of donor-site complications, which occurred in 11 cases (5.5 percent). The median hospital stay for the entire population was 16 days. The development of complications increased the median hospital stay by 7.5 days (p < 0.001). The effect of the development of complication on hospital stay remained significant even after controlling for the effects of confounding variables (relative risk = 9.87; 95 percent CI = 5.9 to 19.9). Microvascular surgery is a highly successful and relatively safe method for the reconstruction of large head and neck defects. The Charlson comorbidity index grading may be useful for identifying patients at increased risk for the development of complications after microvascular reconstruction, allowing for improved perioperative planning. In addition, patients with prior radiation exposure have a significantly higher risk for developing complications at the recipient site. Although advanced age is not associated with an increased risk for complications, older patients may be more sensitive to the effects of prolonged anesthesia and are likely to develop more severe complications.

Free flap reexploration: Indications, treatment, and outcomes in 1193 free flaps

Background: Microvascular free tissue transfer is a reliable method for reconstruction of complex surgical defects. However, there is still a small risk of flap compromise necessitating urgent reexploration. A comprehensive study examining the causes and methods of avoiding or treating these complications has not been performed. The purpose of this study was to review the authors’ experience with a large number of microvascular complications over an 11-year period. Methods: This was a retrospective review of all free flaps performed from 1991 to 2002 at Memorial Sloan-Kettering Cancer Center. All patients who required emergent reexploration were identified, and the incidence of vascular complications and methods used for their management were analyzed. Results: A total of 1193 free flaps were performed during the study period, of which 6 percent required emergent reexploration. The most common causes for reexploration were pedicle thrombosis (53 percent) and hematoma/bleeding (30 percent). The overall flap survival rate was 98.8 percent. Venous thrombosis was more common than arterial thrombosis (74 versus 26 percent) and had a higher salvage rate (71 versus 40 percent). Salvaged free flaps were reexplored more quickly than failed flaps (4 versus 9 hours after detection; p = 0.01). There was no significant difference in salvage rate in flaps requiring secondary vein grafting or thrombolysis as compared with those with anastomotic revision only. Conclusions: Microvascular free tissue transfer is a reliable reconstructive technique with low failure rates. Careful monitoring and urgent reexploration are critical for salvage of compromised flaps. The majority of venous thromboses can be salvaged. Arterial thromboses can be more problematic. An algorithm for flap exploration and salvage is presented.

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 classification system and algorithm for reconstruction of maxillectomy and midfacial defects.

Maxillectomy defects become more complex when critical structures such as the orbit, globe, and cranial base are resected, and reconstruction with distant tissues becomes essential. This study reviews all maxillectomy defects reconstructed immediately using pedicled and free flaps to establish (1) a classification system and (2) an algorithm for reconstruction of these complex problems. Over a 5-year period, 60 flaps were used to reconstruct defects classified as the following: type I, limited maxillectomy (n = 7); type II, subtotal maxillectomy (n = 10); type IIIa, total maxillectomy with preservation of the orbital contents (n = 13); type IIIb, total maxillectomy with orbital exenteration (n = 18); and type IV, orbitomaxillectomy (n = 10). Free flaps (45 rectus abdominis and 10 radial forearm) were used in 55 patients (91.7 percent), and the temporalis muscle was transposed in five elderly patients who were not free-flap candidates. Vascularized (radial forearm osteocutaneous) bone flaps were used in four of the 60 patients (6.7 percent) and nonvascularized bone grafts in 17 (28.3 percent). Simultaneous reconstruction of the oral commissure using an Estandler procedure was performed in 10 patients with maxillectomy and through-and-through soft-tissue defects. Free-flap survival was 100 percent, with reexploration in five of 55 patients (9.1 percent) and partial-flap necrosis in one patient. Seven of the 60 patients (11.7 percent) had systemic complications, and four died within 30 days of hospitalization. Fifty patients had more than 6 months of follow-up with a mean time of 27.7 (±15.6) months. Postoperative radiotherapy was administered in 32 of these patients (64.0 percent). Chewing and speech functions were assessed in 36 patients with type II, IIIa, and IIIb defects. A prosthetic denture was fixed in 15 of 36 patients (41.7 percent). Return to an unrestricted diet was seen in 16 patients (44.4 percent), a soft diet in 17 (47.2 percent), and a liquid diet in three (8.3 percent). Speech was assessed as normal in 14 of 36 patients (38.9 percent), near normal in 15 (41.7 percent), intelligible in six (16.7 percent), and unintelligible in one patient (2.8 percent). Globe and periorbital soft-tissue position was assessed in 14 patients with type I and IIIa defects. There were no cases of enophthalmos, and one patient had a mild vertical dystopia. Ectropion was observed in 10 of 14 patients (71.4 percent). Oral competence was considered good in all 10 patients with excision/reconstruction of the oral commissure; however, two patients (20 percent) developed microstomia after receiving radiotherapy. Aesthetic results were evaluated at least 6 months after reconstruction in 50 patients. They were good to excellent in 29 patients (58 percent) for whom cheek skin and lip were not resected, and poor to fair (42 percent) when the external skin or orbital contents were excised. Secondary procedures were required in 16 of 50 patients (32.0 percent). Free-tissue transfer provides the most effective and reliable form of immediate reconstruction for complex maxillectomy defects. The rectus abdominis and radial forearm flaps in combination with immediate bone grafting or as osteocutaneous flaps reliably provide the best aesthetic and functional results. An algorithm based on the type of maxillary resection can be followed to determine the best approach to reconstruction.

Efficacy of conventional monitoring techniques in free tissue transfer: an 11-year experience in 750 consecutive cases.

Conventional free flap monitoring techniques (clinical observation, hand-held Doppler ultrasonography, surface temperature probes, and pinprick testing) are proven methods for monitoring free flaps with an external component. Buried free flaps lack an external component; thus, conventional monitoring is limited to hand-held Doppler ultrasonography. Free flap success is enhanced by the rapid identification and salvage of failing flaps. The purpose of this study was to compare the salvage rate and final outcomes of buried versus nonburied flaps monitored by conventional techniques. This study is a retrospective review of 750 free flaps performed between 1986 and 1997 for reconstruction of oncologic surgical defects. There were 673 nonburied flaps and 77 buried flaps. All flaps were monitored by using conventional techniques. Both buried and nonburied flaps were used for head and neck and extremity reconstruction. Only nonburied flaps were used for trunk and breast reconstruction. Buried flap donor sites included jejunum (n = 50), fibula (n = 16), forearm (n = 8), rectus abdominis (n = 2), and temporalis fascia (n = 1). Overall flap loss for 750 free flaps was 2.3 percent. Of the 77 buried flaps, 5 flaps were lost, yielding a loss rate of 6.5 percent. The loss rate for nonburied flaps (1.8 percent) was significantly lower than for buried flaps (p = 0.02, Fishers exact test). Fifty-seven (8.5 percent) of the nonburied flaps were reexplored for either change in monitoring status or a wound complication. Reexploration occurred between 2 and 400 hours postoperatively (mean, 95 hours). All 44 of the salvaged flaps were nonburied; these were usually reexplored early (<48 hours) for a change in the monitoring status. Flap compromise in buried flaps usually presented late (>7 days) as a wound complication (infection, fistula). None of five buried flaps were salvageable at the time of reexploration. The overall salvage rate of nonburied flaps (77 percent) was significantly higher than that of buried flaps (0 percent, p<0.001, chi-square test). Conventional monitoring of nonburied free flaps has been highly effective in this series. These techniques have contributed to rapid identification of failing flaps and subsequent salvage in most cases. As such, conventional monitoring has led to an overall free flap success rate commensurate with current standards. In contrast, conventional monitoring of buried free flaps has not been reliable. Failing buried flaps were identified late and found to be unsalvageable at reexploration. Thus, the overall free flap success rate was significantly lower for buried free flaps. To enhance earlier identification of flap compromise in buried free flaps, alternative monitoring techniques such as implantable Doppler probes or exteriorization of flap segments are recommended.

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 Review of 716 Consecutive Free Flaps for Oncologic Surgical Defects: Refinement in Donor-site Selection and Technique

&NA; Free‐tissue transfer has become an important method for reconstructing complex oncologic surgical defects. This study is a retrospective review of a 10‐year experience with 716 consecutive free flaps in 698 patients. Regional applications included the head and neck (69 percent), trunk and breast (14 percent), lower extremity (12 percent), and upper extremity (5 percent). Donor sites included the rectus abdominis (195), fibula (193), forearm (133), latissimus dorsi (69), jejunum (55), gluteus (28), scapula (26), and seven others (17). Microvascular anastomoses were performed to large‐caliber recipient vessels using a continuous suture technique; end‐to‐end anastomoses were preferred (75 percent). Flaps were designed to avoid the need for vein grafts. Conventional postoperative flap monitoring methods were used. These included clinical observation supplemented by Doppler ultrasonography, surface temperature probes, and pin prick testing. Buried flaps were either evaluated with Doppler ultrasonography or not monitored. The overall success rate for free‐flap reconstruction of oncologic surgical defects was 98 percent. Fifty‐seven flaps (8 percent) were reexplored for either anastomotic or infectious problems. Reexplored flaps were salvaged in 40 cases (70 percent). Surviving flaps resulted in a healed wound and did not delay postoperative radiation or chemotherapy. The incidence of major and minor postoperative complications was 34 percent. The mean duration of hospitalization was 20 days, and the average cost was

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.

40,224. The results of this study support the need for only seven donor sites to solve the majority (98 percent) of oncologic problems requiring microsurgical expertise. The evolution of preferred donor sites for specific regional applications is illustrated in this 10‐year experience. Technical refinements have simplified performing the microsurgical anastomoses and essentially eliminated the need for vein grafts. Conventional monitoring has led to the rapid identification of vascular compromise and subsequent flap salvage in the majority of non‐buried free flaps. (Plast. Reconstr. Surg. 102: 722, 1998.)