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Incidence of Complications in Outpatient Mastectomy with Immediate Reconstruction
Incidence of Complications in Outpatient Mastectomy with Immediate Reconstruction Scott A Simpson, BA, Benjamin L Ying, BA, Lisa A Ross, MD, David J Friedman, MD, FACS, Mohammed I Quraishi, BS, Avez A Rizvi, MS, Stephanie F Bernik, MD, FACS Although breast surgery, including mastectomy, is increasingly being performed on an outpatient basis, skepticism remains about the safety of outpatient mastectomy with immediate breast reconstruction. Studies have demonstrated a psychologic benefit to outpatient breast surgery in addition to the clear financial benefit. We sought to determine whether or not the postoperative complication rate after outpatient mastectomy with immediate reconstruction is low enough to consider the procedure safe and effective. STUDY DESIGN: Charts were retrospectively reviewed for all patients who underwent outpatient mastectomies with immediate breast reconstruction at St Vincent’s Comprehensive Cancer Center between December 2000 and June 2004. The presence or absence of postoperative complications was determined from records during the postoperative period and subsequent office visit. RESULTS: Of 29 outpatient mastectomies with immediate reconstruction performed on 28 patients (one had independent procedures on each breast), only one procedure (3%) required subsequent admission to the hospital (for bleeding). Other complications included three seromas, two cases of cellulitis requiring antibiotics, and one hematoma. The overall complication rate was 24% (7 of 29), with only 14% (1 of 7) of the complications requiring hospitalization. CONCLUSIONS: These results demonstrate that outpatient mastectomy with immediate reconstruction is a safe and effective procedure for carefully selected patients. The complication rates for our patient population are similar to those in other published reports on outpatient operations, most notably, those of outpatient mastectomy without immediate reconstruction. (J Am Coll Surg 2007;205:463–467. © 2007 by the American College of Surgeons) BACKGROUND:
Breast surgery, including mastectomy, is increasingly being performed on an outpatient basis. In the medical community and the general public, however, the notion lingers that for more invasive procedures, such as mastectomy with immediate reconstruction, outpatient surgery constitutes a lower standard of care and is merely a cost-saving initiative on the part of hospitals and physicians. Earlier studies have shown that outpatient breast surgery reduces both hospital and patient costs1-3 and have suggested that patients experience faster psychologic recovery after outpatient procedures.1,2,4 Studies have also reported low rates of postsurgical complications for out-
patient operations.1,5-7 Very few data, however, are available on complication rates after mastectomy with immediate first-stage reconstruction.8 To our knowledge, this is the first published study on complication rates after outpatient mastectomy with immediate reconstruction, a procedure we have found to be safe and effective in selected patients. METHODS We retrospectively reviewed surgical and implant and tissue expander logs at St Vincent’s Comprehensive Cancer Center (SVCCC), an outpatient center, between December 2000 and June 2004, to identify patients who underwent mastectomies with immediate breast reconstruction. The mastectomy was performed by one of three dedicated breast surgeons, and the reconstruction was done by a plastic surgeon in all patients. Patient charts and SVCCC electronic databases were subsequently examined. Followup information, in the form of dictated notes from postoperative visits in the surgeon’s
Competing Interests Declared: None. Received January 27, 2007; Revised March 14, 2007; Accepted March 27, 2007. From the Department of Surgery, St Vincent’s Comprehensive Cancer Center, New York, NY. Correspondence address: Stephanie F Bernik, MD, FACS, St Vincent’s Comprehensive Cancer Center, 325 W 15th Street, New York, NY 10011.
© 2007 by the American College of Surgeons Published by Elsevier Inc.
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ISSN 1072-7515/07/$32.00 doi:10.1016/j.jamcollsurg.2007.03.030
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Abbreviations and Acronyms
ALND ⫽ axillary lymph node dissection ASA ⫽ American Society of Anesthesiologists SVCCC ⫽ St Vincent’s Comprehensive Cancer Center
office and checklists from followup phone calls by nurses, was examined, and any postoperative complications were noted. Postoperative complications were separated into minor complications (those easily treated in subsequent outpatient visits, including seroma, hematoma, and cellulitis) and major complications (those requiring hospital admission). Mastectomy patients at SVCCC who opted for breast reconstruction consulted with a plastic surgeon to determine the method and timing of reconstruction. The criteria for selecting patients for outpatient mastectomy followed by immediate tissue expander placement were multifaceted. Patient motivation was the primary factor in initiating the consideration to go forward with operations on an outpatient basis. Some patients preferred to go home on the day of their operation to resume their daily activities as soon as possible. Some may have had an aversion to or phobia of hospitals. From the perspective of the plastic surgeon, ideal candidates for outpatient mastectomies with immediate reconstruction were young patients in good health. Advanced age alone, however, did not exclude a patient. In this study, eight patients were 60 years of age or older, and none experienced any major complications. Medical conditions that excluded a patient from outpatient treatment include active cardiovascular issues, known coagulation problems, and uncontrolled diabetes. From an anesthesia standpoint, only patients of ASA classes I to III (American Society of Anesthesiologists risk classification) with no earlier history of hospital admission for intractable vomiting, severe anesthetic reaction, or both, were accepted. Patients considered for outpatient treatment were deemed reliable (eg, would be responsible in caring for themselves, would seek medical attention if complications arose, and would come to followup) and had adequate support, with someone to stay with them for at least the first night after surgery. RESULTS Breast surgeons at SVCCC operate on an outpatient basis at SVCCC and on an inpatient basis at St Vincent’s
J Am Coll Surg
Hospital Manhattan. Outpatient surgery schedules were available for review for all three SVCCC breast surgeons during the time period of data collection for this study, but inpatient surgery schedules were available for review for only two of the three breast surgeons. To compare the number of inpatient and outpatient procedures during the period of data collection, we included data from only the two surgeons for whom both schedules were available: 23 (15%) of the two surgeons’ combined 155 immediate breast reconstruction procedures were outpatient tissue expander placements, 46 (30%) were inpatient tissue expander placements, 77 (50%) were inpatient transrectus abdominis muscle (TRAM) flap reconstructions, and 9 (6%) were inpatient latissimus dorsi flap reconstructions. Including data from all 3 breast surgeons operating during the study period, 29 outpatient mastectomies with immediate reconstruction were performed on 28 women at SVCCC. All were unilateral procedures. Twenty-eight of the 29 procedures were mastectomies with immediate tissue expander insertion; the 29th was a mastectomy with immediate replacement of an earlier cosmetic implant. Twenty-six of the 28 tissue expanders inserted were McGhan 133 series units (133MV, 133FV, and 133LV). The remaining two were Mentor contour profile series units. The average stated expander volume was 441 mL (median 400 mL, range 300 to 650 mL). An average of 15% of the stated expander volume was initially injected into the expanders (median 15%, range 0% to 36%). Twenty-four procedures were followed by implant exchanges that were also performed at SVCCC on an outpatient basis, and five implant exchanges were performed at outside institutions. Mean patient age at the time of mastectomy was 46 years (median 43 years, range 29 to 68 years). The average operation time was 110 minutes (median 107 minutes, range 76 to 165 minutes). Preoperative Percocet (Endo Pharmaceuticals, 1 to 2 tablets) was given to patients in 27 of the 29 procedures. All patients were induced with propofol through either an endotracheal tube or laryngeal mask airway. They also received IV fentanyl (intraoperatively, on induction, or both) and intraoperative midazolam. Intraoperative Zofran (GlaxoSmithKline) was administered in 25 of the 29 procedures and intraoperative Anzemet (Aventis Pharmaceuticals) was administered in 3 of the 29 procedures. Marcaine (AstraZeneca) was used in one procedure at the time of closure.
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Table 1. Postoperative Complications Separated by Patient American Society of Anesthesiologists Class ASA class
I II III Total
Seroma
Hematoma
0 3 0 3
1 0 0 1
Complication Cellulitis
1 1 0 2
Uncontrolled bleeding
Total
0 1 0 1
2 5 0 7
ASA, American Society of Anesthesiologists.
In addition to mastectomy, 21 of the 29 procedures included a sentinel lymph node biopsy (SLNB). On average, 2 sentinel lymph nodes were biopsied (range 2 to 5 nodes). In 4 of the 21 sentinel lymph node biopsies, at least 1 node was found to contain metastasis during the intraoperative consult, which resulted in a subsequent axillary lymph node dissection (ALND). There was case of a planned axillary dissection, which followed a previous sentinel lymph node biopsy that had been positive for metastasis. The average number of lymph nodes harvested during the 5 ALND procedures was 14 (range 8 to 20). Seven patients had no axillary intervention at the time of mastectomy. Each patient had either one or two medium and, or large Jackson-Pratt (JP) drains, which were removed during the followup visit. The average time spent in the postsurgical care unit was 256 minutes (median 228 minutes, range 139 to 515 minutes). In 25 patients, fentanyl was administered postoperatively. Other drugs given during recovery included Zofran (GlaxoSmithKline), metoclopramide, Percocet (Endo Pharmaceuticals), acetaminophen, Anzemet (Aventis), Toradol (Roche), Maalox (Novartis), labetalol, and droperidol. Patients were generally discharged with prescriptions for Tylenol or Vicodin for pain and Keflex or Clindamycin as a prophylactic antibiotic. There were 23 patients who had unilateral invasive carcinoma (21 ductal, 1 lobular, 1 mixed). One of these patients opted for a prophylactic mastectomy of the contralateral breast 9 months after her first mastectomy. Of the remaining five patients, four had ductal carcinoma in situ and one had a phyllodes tumor. Followup information, in the form of dictated notes from postoperative visits in the breast surgeon’s office, was available for review. Records from answered followup phone calls by nurses were available for 23 patients and averaged 2 days after surgery (range 1 to 4 days). Postoperative office visits averaged 16 days after surgery (range 9 to 41 days).
One of the 29 (3%) procedures required subsequent admission to the hospital for bleeding. Minor complications diagnosed at the time of postoperative visits occurred 21% of the time and included three seromas, two cases of cellulitis requiring antibiotics, and one hematoma. So the overall complication rate was 24% (3% major and 21% minor). All minor complications were treated on an outpatient basis during the followup appointment; none required hospital admission, reoperation, removal of the tissue expander, or IV antibiotics. During followup phone calls, no patients reported pain that was not adequately handled by oral pain medication. All patients reported to have resumed normal activities of daily living and normal diets at the time of the call. Two patients (9%) reported nausea and vomiting: one stopped vomiting after cessation of pain medication and the other was advised to call her plastic surgeon for advice. Twenty-eight procedures (97%) were on patients classified at the time of operation as ASA class I or II (Table 1). Eleven (38%) were class I and 17 (59%) were class II. Only one procedure (3%) was on a patient of ASA class III, and no complication was reported at the time of her followup office visit or phone call. Two of the 11 (18%) patients classified as ASA class I at the time of operation experienced complications, compared with 5 of the 17 (29%) ASA class II patients. One patient with a hematoma and one with cellulitis were classified as ASA class I. The other five complications, including a case of postoperative bleeding for which the patient was admitted to the hospital, occurred in patients of ASA class II. We found no statistically significant difference in the complication rate for ASA class I and II patients (p ⫽ 0.668, Fisher’s exact test). The patient admitted to the hospital for bleeding had her mastectomy and immediate reconstruction completed in 117 minutes. While in recovery, she had sanguinous drainage without any evidence of clotting. The drainage did not stop with compression. The patient
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remained in recovery for approximately 3.5 hours before being brought back to the operating room. After induction of general anesthesia, the wound was opened and the drain removed, and no evidence of clotting was noted. The wound was irrigated with thrombin, and a piece of Gelfoam (Pfizer) was cut to size and placed against the axilla. A new drain was placed and the patient was sutured and wrapped in an elastic bandage. She was transferred to the recovery room in stable condition. While in recovery, the patient continued to have excessive drainage out of the Jackson-Pratt drain. Her prothrombin time (PT) was 12.4 seconds (normal range 10.8 to 12.4 seconds), international normalized ratio (INR) was 1.19 seconds (normal range 0.80 to 1.20 seconds), and partial thromboplastin time (PTT) was 35.0 seconds (normal range 25.7 to 36.3 seconds). Her hemoglobin level was 11.7 g/dL and hematocrit level was 34.7%. It was estimated that the patient lost 300 mL of blood while at the cancer center. She was admitted to the hospital and stayed for approximately 36 hours. During this time, she was given morphine and IV fluids. After 16 hours, she received three blood transfusions: 375 mL of red blood cells, 292 mL of platelets, and another 375 mL of red blood cells in an 8-hour period. She was also given one dose of vitamin K during her stay. At her followup, 7 days postoperatively, she was noted to be healing normally and her laboratory values were within normal range. The facility costs of outpatient mastectomy with immediate reconstruction at SVCCC ranged from $3,130.88 to $5,807.70, and the range for the same procedure on an inpatient basis at St Vincent’s Hospital Manhattan was $3,435.75 to $6,433.75.3 The difference in the average facility cost of the inpatient procedure versus the outpatient procedure was statistically significant (p ⬍ 0.006, two-tailed t-test). Each night in the hospital added $518.00 in costs, with 60% of inpatients staying two or more nights.3 DISCUSSION To our knowledge, this is the first study examining postoperative complications in patients undergoing outpatient mastectomy with immediate reconstruction. There are other studies that have discussed the safety and efficacy of outpatient breast conservative surgery (both with and without an ALND) and mastectomy without immediate breast reconstruction. Other authors, particularly those publishing in the early years of the debate over
J Am Coll Surg
the efficacy of outpatient breast surgery, suggested that regardless of the potential safety of outpatient mastectomy without immediate reconstruction, outpatient mastectomy with immediate reconstruction was not a viable option. This was illustrated by McManus and colleagues2 who found mastectomy patients receiving immediate reconstruction required hospitalization for several days. The authors also believed the rate of outpatient mastectomy would not increase substantially because many patients would opt for immediate reconstruction, which they believed should not be performed on an outpatient basis.2 The financial benefits of outpatient procedures, to both patients and hospitals, are clear,1-3 and the improved psychologic recovery of patients who have surgery in the outpatient setting has been reported in numerous studies.1,2,4 The psychologic benefit of immediate reconstruction has also been shown in numerous studies.9-13 In a prominent example of the psychologic benefit of outpatient treatment, Margolese and Lasry4 reported data from both inpatient and outpatient ALND (many of which were preceded by mastectomy). One author changed his practice of ALND treatment from solely inpatient to solely outpatient 5 years before publication. This sudden change in practice provided a group of unselected patients (comprised of all patients undergoing ALND) for both the outpatient and inpatient arms of their retrospective study. Fifty-five outpatients and 45 inpatients were given a patient survey with questions related to time to recovery (physical and psychologic), pain, and anxiety. Outpatients reported substantially better emotional adjustment after surgery and reported feeling “recovered from surgery” an average of 10 days sooner than the inpatient group. Studies of outpatient procedures have reported complication rates low enough to establish that outpatient care is safe and effective. In their study of 192 outpatient partial mastectomies, total mastectomies, and ALNDs, Goodman and Armando1 offered patients the option to have outpatient surgery instead of inpatient surgery unless they were excluded based on the primary physician’s or anesthesiologist’s judgment. They reported no deaths, no readmissions, no wound infections, and a rate of seroma ⬍ 15%. Tan and Guenther5 found no complications, readmissions, or deaths after 50 outpatient simple mastectomies, modified radical mastectomies, or ALNDs. They reported that advanced age and late surgery time did not appear to be contraindications for outpatient
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treatment. Athey and associates6 reported the results of 165 intended outpatient axillary dissections (16 were admitted overnight, usually because of late operation time, but also 2 for nausea and 1 for a hematoma). Twenty-nine patients underwent ALND alone and 136 patients underwent ALND with wide local excision. The authors found a 22% seroma rate and 10% wound infection rate. In 50 ALNDs with wide local excision, Marchal and coworkers7 reported 2 (4%) abscesses, 14 (28%) seromas, no hematomas, and no bleeding requiring hospital admission. In addition to the studies establishing the safety of outpatient breast surgery, other studies have shown the safety of immediate breast reconstruction, although so far, only on an inpatient basis. In 83 expander and, or implant reconstructions, Nano and colleagues14 found 18 complications: 3 hematomas, 3 infections with 2 leading to loss of the implant, 5 implant ruptures, 5 cases of grade 3 contracture and, or radionecrosis, and 2 cases of chronic pain. Their followup ranged from 6 months to 10 years. Nahabedian and associates15 found a 5.9% infection rate among 136 immediate expander and, or implant reconstructions. They found the only statistically significant predictor of infection to be having received radiation therapy after implant insertion. Our study supports the findings that outpatient surgery is safe and effective. With only one procedure (3%) requiring hospitalization of the patient for a postoperative complication and six procedures (21%) with subsequent complications easily treated at scheduled postoperative office visits, our data suggest that outpatient mastectomy with immediate reconstruction is a safe and effective option for carefully selected patients. Our complication rates are similar to those in other published reports on outpatient operations, most notably, those of outpatient mastectomy without immediate reconstruction. With doctors assessing patient suitability for outpatient treatment, a scheme of optimum efficiency and the shortest patient recovery time can be achieved with mastectomy and immediate reconstruction. In addition to minimizing patient recovery time and optimizing psychologic well-being, outpatient mastectomy and reconstruction decreases costs to both hospitals and patients.
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Author Contributions Study conception and design: Simpson, Ross, Bernik Acquisition of data: Simpson, Ying, Friedman, Ross, Quraishi, Rizvi, Bernik Analysis and interpretation of data: Simpson, Ying, Bernik Drafting of manuscript: Simpson, Ying, Quraishi, Rizvi Critical revision: Ying, Ross, Friedman, Bernik REFERENCES 1. Goodman AA, Armando LM. Definitive surgery for breast cancer performed on an outpatient basis. Arch Surg 1993;128: 1149–1152. 2. McManus SA, Topp DA, Hopkins C. Advantages of outpatient breast surgery. Am Surg 1994;60:967–970. 3. Ross LA, Axelrod DA, Bernik SF, et al. Cost analysis of outpatient vs. inpatient mastectomy with first stage reconstruction [poster]. Federal Ambulatory Surgery Association annual meeting 2006. 4. Margolese RG, Lasry JM. Ambulatory surgery for breast cancer patients. Ann Surg Oncol 2000;7:181–187. 5. Tan LR, Guenther JM. Outpatient definitive breast cancer surgery. Am Surg 1997;63:865–867. 6. Athey N, Gilliam AD, Sinha P, et al. Day-case breast cancer axillary surgery. Ann R Coll Surg Engl 2005;87:96–98. 7. Marchal F, Dravet F, Classe JM, et al. Post-operative care and patient satisfaction after ambulatory surgery for breast cancer patients. Eur J Surg Oncol 2005;31:495–499. 8. Ahmed S, Snelling A, Bains M, et al. Breast reconstruction. BMJ 2005;330:943–948. 9. Al-Ghazal SK, Sully L, Fallowfield L, et al. The psychological impact of immediate rather than delayed breast reconstruction. Eur J Surg Oncol 2000;26:17–19. 10. Dean C, Chetty U, Forrest AP. Effects of immediate breast reconstruction on psychosocial morbidity after mastectomy. Lancet 1983;1:459–462. 11. Stevens LA, McGrath MH, Druss RG, et al. The psychological impact of immediate breast reconstruction for women with early breast cancer. Plast Reconstr Surg 1984;73:619–628. 12. Wellisch DK, Schain WS, Noone RB, et al. Psychosocial correlates of immediate versus delayed reconstruction of the breast. Plast Reconstr Surg 1985;76:713–718. 13. Wilkins EG, Cederna PS, Lowery JC, et al. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg 2000;106:1014–1025. 14. Nano MT, Gill PG, Kollias J, et al. Qualitative assessment of breast reconstruction in a specialist breast unit. ANZ J Surg 2005;75:445–453. 15. Nahabedian MY, Tsangaris T, Momen B, et al. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg 2003;112:467–476.
Breast surgery, including mastectomy, is increasingly being performed on an outpatient basis. In the medical community and the general public, however, the notion lingers that for more invasive procedures, such as mastectomy with immediate reconstruction, outpatient surgery constitutes a lower standard of care and is merely a cost-saving initiative on the part of hospitals and physicians. Earlier studies have shown that outpatient breast surgery reduces both hospital and patient costs1-3 and have suggested that patients experience faster psychologic recovery after outpatient procedures.1,2,4 Studies have also reported low rates of postsurgical complications for out-
patient operations.1,5-7 Very few data, however, are available on complication rates after mastectomy with immediate first-stage reconstruction.8 To our knowledge, this is the first published study on complication rates after outpatient mastectomy with immediate reconstruction, a procedure we have found to be safe and effective in selected patients. METHODS We retrospectively reviewed surgical and implant and tissue expander logs at St Vincent’s Comprehensive Cancer Center (SVCCC), an outpatient center, between December 2000 and June 2004, to identify patients who underwent mastectomies with immediate breast reconstruction. The mastectomy was performed by one of three dedicated breast surgeons, and the reconstruction was done by a plastic surgeon in all patients. Patient charts and SVCCC electronic databases were subsequently examined. Followup information, in the form of dictated notes from postoperative visits in the surgeon’s
Competing Interests Declared: None. Received January 27, 2007; Revised March 14, 2007; Accepted March 27, 2007. From the Department of Surgery, St Vincent’s Comprehensive Cancer Center, New York, NY. Correspondence address: Stephanie F Bernik, MD, FACS, St Vincent’s Comprehensive Cancer Center, 325 W 15th Street, New York, NY 10011.
© 2007 by the American College of Surgeons Published by Elsevier Inc.
463
ISSN 1072-7515/07/$32.00 doi:10.1016/j.jamcollsurg.2007.03.030
464
Simpson et al
Outpatient Immediate Breast Reconstruction
Abbreviations and Acronyms
ALND ⫽ axillary lymph node dissection ASA ⫽ American Society of Anesthesiologists SVCCC ⫽ St Vincent’s Comprehensive Cancer Center
office and checklists from followup phone calls by nurses, was examined, and any postoperative complications were noted. Postoperative complications were separated into minor complications (those easily treated in subsequent outpatient visits, including seroma, hematoma, and cellulitis) and major complications (those requiring hospital admission). Mastectomy patients at SVCCC who opted for breast reconstruction consulted with a plastic surgeon to determine the method and timing of reconstruction. The criteria for selecting patients for outpatient mastectomy followed by immediate tissue expander placement were multifaceted. Patient motivation was the primary factor in initiating the consideration to go forward with operations on an outpatient basis. Some patients preferred to go home on the day of their operation to resume their daily activities as soon as possible. Some may have had an aversion to or phobia of hospitals. From the perspective of the plastic surgeon, ideal candidates for outpatient mastectomies with immediate reconstruction were young patients in good health. Advanced age alone, however, did not exclude a patient. In this study, eight patients were 60 years of age or older, and none experienced any major complications. Medical conditions that excluded a patient from outpatient treatment include active cardiovascular issues, known coagulation problems, and uncontrolled diabetes. From an anesthesia standpoint, only patients of ASA classes I to III (American Society of Anesthesiologists risk classification) with no earlier history of hospital admission for intractable vomiting, severe anesthetic reaction, or both, were accepted. Patients considered for outpatient treatment were deemed reliable (eg, would be responsible in caring for themselves, would seek medical attention if complications arose, and would come to followup) and had adequate support, with someone to stay with them for at least the first night after surgery. RESULTS Breast surgeons at SVCCC operate on an outpatient basis at SVCCC and on an inpatient basis at St Vincent’s
J Am Coll Surg
Hospital Manhattan. Outpatient surgery schedules were available for review for all three SVCCC breast surgeons during the time period of data collection for this study, but inpatient surgery schedules were available for review for only two of the three breast surgeons. To compare the number of inpatient and outpatient procedures during the period of data collection, we included data from only the two surgeons for whom both schedules were available: 23 (15%) of the two surgeons’ combined 155 immediate breast reconstruction procedures were outpatient tissue expander placements, 46 (30%) were inpatient tissue expander placements, 77 (50%) were inpatient transrectus abdominis muscle (TRAM) flap reconstructions, and 9 (6%) were inpatient latissimus dorsi flap reconstructions. Including data from all 3 breast surgeons operating during the study period, 29 outpatient mastectomies with immediate reconstruction were performed on 28 women at SVCCC. All were unilateral procedures. Twenty-eight of the 29 procedures were mastectomies with immediate tissue expander insertion; the 29th was a mastectomy with immediate replacement of an earlier cosmetic implant. Twenty-six of the 28 tissue expanders inserted were McGhan 133 series units (133MV, 133FV, and 133LV). The remaining two were Mentor contour profile series units. The average stated expander volume was 441 mL (median 400 mL, range 300 to 650 mL). An average of 15% of the stated expander volume was initially injected into the expanders (median 15%, range 0% to 36%). Twenty-four procedures were followed by implant exchanges that were also performed at SVCCC on an outpatient basis, and five implant exchanges were performed at outside institutions. Mean patient age at the time of mastectomy was 46 years (median 43 years, range 29 to 68 years). The average operation time was 110 minutes (median 107 minutes, range 76 to 165 minutes). Preoperative Percocet (Endo Pharmaceuticals, 1 to 2 tablets) was given to patients in 27 of the 29 procedures. All patients were induced with propofol through either an endotracheal tube or laryngeal mask airway. They also received IV fentanyl (intraoperatively, on induction, or both) and intraoperative midazolam. Intraoperative Zofran (GlaxoSmithKline) was administered in 25 of the 29 procedures and intraoperative Anzemet (Aventis Pharmaceuticals) was administered in 3 of the 29 procedures. Marcaine (AstraZeneca) was used in one procedure at the time of closure.
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Table 1. Postoperative Complications Separated by Patient American Society of Anesthesiologists Class ASA class
I II III Total
Seroma
Hematoma
0 3 0 3
1 0 0 1
Complication Cellulitis
1 1 0 2
Uncontrolled bleeding
Total
0 1 0 1
2 5 0 7
ASA, American Society of Anesthesiologists.
In addition to mastectomy, 21 of the 29 procedures included a sentinel lymph node biopsy (SLNB). On average, 2 sentinel lymph nodes were biopsied (range 2 to 5 nodes). In 4 of the 21 sentinel lymph node biopsies, at least 1 node was found to contain metastasis during the intraoperative consult, which resulted in a subsequent axillary lymph node dissection (ALND). There was case of a planned axillary dissection, which followed a previous sentinel lymph node biopsy that had been positive for metastasis. The average number of lymph nodes harvested during the 5 ALND procedures was 14 (range 8 to 20). Seven patients had no axillary intervention at the time of mastectomy. Each patient had either one or two medium and, or large Jackson-Pratt (JP) drains, which were removed during the followup visit. The average time spent in the postsurgical care unit was 256 minutes (median 228 minutes, range 139 to 515 minutes). In 25 patients, fentanyl was administered postoperatively. Other drugs given during recovery included Zofran (GlaxoSmithKline), metoclopramide, Percocet (Endo Pharmaceuticals), acetaminophen, Anzemet (Aventis), Toradol (Roche), Maalox (Novartis), labetalol, and droperidol. Patients were generally discharged with prescriptions for Tylenol or Vicodin for pain and Keflex or Clindamycin as a prophylactic antibiotic. There were 23 patients who had unilateral invasive carcinoma (21 ductal, 1 lobular, 1 mixed). One of these patients opted for a prophylactic mastectomy of the contralateral breast 9 months after her first mastectomy. Of the remaining five patients, four had ductal carcinoma in situ and one had a phyllodes tumor. Followup information, in the form of dictated notes from postoperative visits in the breast surgeon’s office, was available for review. Records from answered followup phone calls by nurses were available for 23 patients and averaged 2 days after surgery (range 1 to 4 days). Postoperative office visits averaged 16 days after surgery (range 9 to 41 days).
One of the 29 (3%) procedures required subsequent admission to the hospital for bleeding. Minor complications diagnosed at the time of postoperative visits occurred 21% of the time and included three seromas, two cases of cellulitis requiring antibiotics, and one hematoma. So the overall complication rate was 24% (3% major and 21% minor). All minor complications were treated on an outpatient basis during the followup appointment; none required hospital admission, reoperation, removal of the tissue expander, or IV antibiotics. During followup phone calls, no patients reported pain that was not adequately handled by oral pain medication. All patients reported to have resumed normal activities of daily living and normal diets at the time of the call. Two patients (9%) reported nausea and vomiting: one stopped vomiting after cessation of pain medication and the other was advised to call her plastic surgeon for advice. Twenty-eight procedures (97%) were on patients classified at the time of operation as ASA class I or II (Table 1). Eleven (38%) were class I and 17 (59%) were class II. Only one procedure (3%) was on a patient of ASA class III, and no complication was reported at the time of her followup office visit or phone call. Two of the 11 (18%) patients classified as ASA class I at the time of operation experienced complications, compared with 5 of the 17 (29%) ASA class II patients. One patient with a hematoma and one with cellulitis were classified as ASA class I. The other five complications, including a case of postoperative bleeding for which the patient was admitted to the hospital, occurred in patients of ASA class II. We found no statistically significant difference in the complication rate for ASA class I and II patients (p ⫽ 0.668, Fisher’s exact test). The patient admitted to the hospital for bleeding had her mastectomy and immediate reconstruction completed in 117 minutes. While in recovery, she had sanguinous drainage without any evidence of clotting. The drainage did not stop with compression. The patient
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remained in recovery for approximately 3.5 hours before being brought back to the operating room. After induction of general anesthesia, the wound was opened and the drain removed, and no evidence of clotting was noted. The wound was irrigated with thrombin, and a piece of Gelfoam (Pfizer) was cut to size and placed against the axilla. A new drain was placed and the patient was sutured and wrapped in an elastic bandage. She was transferred to the recovery room in stable condition. While in recovery, the patient continued to have excessive drainage out of the Jackson-Pratt drain. Her prothrombin time (PT) was 12.4 seconds (normal range 10.8 to 12.4 seconds), international normalized ratio (INR) was 1.19 seconds (normal range 0.80 to 1.20 seconds), and partial thromboplastin time (PTT) was 35.0 seconds (normal range 25.7 to 36.3 seconds). Her hemoglobin level was 11.7 g/dL and hematocrit level was 34.7%. It was estimated that the patient lost 300 mL of blood while at the cancer center. She was admitted to the hospital and stayed for approximately 36 hours. During this time, she was given morphine and IV fluids. After 16 hours, she received three blood transfusions: 375 mL of red blood cells, 292 mL of platelets, and another 375 mL of red blood cells in an 8-hour period. She was also given one dose of vitamin K during her stay. At her followup, 7 days postoperatively, she was noted to be healing normally and her laboratory values were within normal range. The facility costs of outpatient mastectomy with immediate reconstruction at SVCCC ranged from $3,130.88 to $5,807.70, and the range for the same procedure on an inpatient basis at St Vincent’s Hospital Manhattan was $3,435.75 to $6,433.75.3 The difference in the average facility cost of the inpatient procedure versus the outpatient procedure was statistically significant (p ⬍ 0.006, two-tailed t-test). Each night in the hospital added $518.00 in costs, with 60% of inpatients staying two or more nights.3 DISCUSSION To our knowledge, this is the first study examining postoperative complications in patients undergoing outpatient mastectomy with immediate reconstruction. There are other studies that have discussed the safety and efficacy of outpatient breast conservative surgery (both with and without an ALND) and mastectomy without immediate breast reconstruction. Other authors, particularly those publishing in the early years of the debate over
J Am Coll Surg
the efficacy of outpatient breast surgery, suggested that regardless of the potential safety of outpatient mastectomy without immediate reconstruction, outpatient mastectomy with immediate reconstruction was not a viable option. This was illustrated by McManus and colleagues2 who found mastectomy patients receiving immediate reconstruction required hospitalization for several days. The authors also believed the rate of outpatient mastectomy would not increase substantially because many patients would opt for immediate reconstruction, which they believed should not be performed on an outpatient basis.2 The financial benefits of outpatient procedures, to both patients and hospitals, are clear,1-3 and the improved psychologic recovery of patients who have surgery in the outpatient setting has been reported in numerous studies.1,2,4 The psychologic benefit of immediate reconstruction has also been shown in numerous studies.9-13 In a prominent example of the psychologic benefit of outpatient treatment, Margolese and Lasry4 reported data from both inpatient and outpatient ALND (many of which were preceded by mastectomy). One author changed his practice of ALND treatment from solely inpatient to solely outpatient 5 years before publication. This sudden change in practice provided a group of unselected patients (comprised of all patients undergoing ALND) for both the outpatient and inpatient arms of their retrospective study. Fifty-five outpatients and 45 inpatients were given a patient survey with questions related to time to recovery (physical and psychologic), pain, and anxiety. Outpatients reported substantially better emotional adjustment after surgery and reported feeling “recovered from surgery” an average of 10 days sooner than the inpatient group. Studies of outpatient procedures have reported complication rates low enough to establish that outpatient care is safe and effective. In their study of 192 outpatient partial mastectomies, total mastectomies, and ALNDs, Goodman and Armando1 offered patients the option to have outpatient surgery instead of inpatient surgery unless they were excluded based on the primary physician’s or anesthesiologist’s judgment. They reported no deaths, no readmissions, no wound infections, and a rate of seroma ⬍ 15%. Tan and Guenther5 found no complications, readmissions, or deaths after 50 outpatient simple mastectomies, modified radical mastectomies, or ALNDs. They reported that advanced age and late surgery time did not appear to be contraindications for outpatient
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treatment. Athey and associates6 reported the results of 165 intended outpatient axillary dissections (16 were admitted overnight, usually because of late operation time, but also 2 for nausea and 1 for a hematoma). Twenty-nine patients underwent ALND alone and 136 patients underwent ALND with wide local excision. The authors found a 22% seroma rate and 10% wound infection rate. In 50 ALNDs with wide local excision, Marchal and coworkers7 reported 2 (4%) abscesses, 14 (28%) seromas, no hematomas, and no bleeding requiring hospital admission. In addition to the studies establishing the safety of outpatient breast surgery, other studies have shown the safety of immediate breast reconstruction, although so far, only on an inpatient basis. In 83 expander and, or implant reconstructions, Nano and colleagues14 found 18 complications: 3 hematomas, 3 infections with 2 leading to loss of the implant, 5 implant ruptures, 5 cases of grade 3 contracture and, or radionecrosis, and 2 cases of chronic pain. Their followup ranged from 6 months to 10 years. Nahabedian and associates15 found a 5.9% infection rate among 136 immediate expander and, or implant reconstructions. They found the only statistically significant predictor of infection to be having received radiation therapy after implant insertion. Our study supports the findings that outpatient surgery is safe and effective. With only one procedure (3%) requiring hospitalization of the patient for a postoperative complication and six procedures (21%) with subsequent complications easily treated at scheduled postoperative office visits, our data suggest that outpatient mastectomy with immediate reconstruction is a safe and effective option for carefully selected patients. Our complication rates are similar to those in other published reports on outpatient operations, most notably, those of outpatient mastectomy without immediate reconstruction. With doctors assessing patient suitability for outpatient treatment, a scheme of optimum efficiency and the shortest patient recovery time can be achieved with mastectomy and immediate reconstruction. In addition to minimizing patient recovery time and optimizing psychologic well-being, outpatient mastectomy and reconstruction decreases costs to both hospitals and patients.
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Author Contributions Study conception and design: Simpson, Ross, Bernik Acquisition of data: Simpson, Ying, Friedman, Ross, Quraishi, Rizvi, Bernik Analysis and interpretation of data: Simpson, Ying, Bernik Drafting of manuscript: Simpson, Ying, Quraishi, Rizvi Critical revision: Ying, Ross, Friedman, Bernik REFERENCES 1. Goodman AA, Armando LM. Definitive surgery for breast cancer performed on an outpatient basis. Arch Surg 1993;128: 1149–1152. 2. McManus SA, Topp DA, Hopkins C. Advantages of outpatient breast surgery. Am Surg 1994;60:967–970. 3. Ross LA, Axelrod DA, Bernik SF, et al. Cost analysis of outpatient vs. inpatient mastectomy with first stage reconstruction [poster]. Federal Ambulatory Surgery Association annual meeting 2006. 4. Margolese RG, Lasry JM. Ambulatory surgery for breast cancer patients. Ann Surg Oncol 2000;7:181–187. 5. Tan LR, Guenther JM. Outpatient definitive breast cancer surgery. Am Surg 1997;63:865–867. 6. Athey N, Gilliam AD, Sinha P, et al. Day-case breast cancer axillary surgery. Ann R Coll Surg Engl 2005;87:96–98. 7. Marchal F, Dravet F, Classe JM, et al. Post-operative care and patient satisfaction after ambulatory surgery for breast cancer patients. Eur J Surg Oncol 2005;31:495–499. 8. Ahmed S, Snelling A, Bains M, et al. Breast reconstruction. BMJ 2005;330:943–948. 9. Al-Ghazal SK, Sully L, Fallowfield L, et al. The psychological impact of immediate rather than delayed breast reconstruction. Eur J Surg Oncol 2000;26:17–19. 10. Dean C, Chetty U, Forrest AP. Effects of immediate breast reconstruction on psychosocial morbidity after mastectomy. Lancet 1983;1:459–462. 11. Stevens LA, McGrath MH, Druss RG, et al. The psychological impact of immediate breast reconstruction for women with early breast cancer. Plast Reconstr Surg 1984;73:619–628. 12. Wellisch DK, Schain WS, Noone RB, et al. Psychosocial correlates of immediate versus delayed reconstruction of the breast. Plast Reconstr Surg 1985;76:713–718. 13. Wilkins EG, Cederna PS, Lowery JC, et al. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg 2000;106:1014–1025. 14. Nano MT, Gill PG, Kollias J, et al. Qualitative assessment of breast reconstruction in a specialist breast unit. ANZ J Surg 2005;75:445–453. 15. Nahabedian MY, Tsangaris T, Momen B, et al. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg 2003;112:467–476.