INTRODUCTION
Breast cancer has currently a growing incidence in younger women, often showing a hereditary component. The early detection of the disease has led to more conservative surgical treatments and better survival outcomes 1. This perspective in the evolution of cancer management has impacted on the type of reconstruction, as well as on patient demand. Expectations are very high in young women seeking for outstanding cosmetic results. Plastic surgeons need to deal with this issue, tailoring patient therapeutic strategies 2,3.
Fast track surgery can be a cost-effective pathway to manage this upcoming demand 4-9.
A multidisciplinary team, innovative technological tools and less invasive procedures make this approach a safe and feasible standard of care.
We started ambulatory surgery for breast reconstruction and refinements in 2010, when a dedicated center was built (IEO day center) to meet this need and nowadays this approach represents the standard of care. Thousands of patients have been successfully treated over the years and they completed their reconstruction after breast cancer.
The purpose of the paper is to demonstrate that fast track surgery for reconstruction and aesthetic refinements is a safe, beneficial and cost-effective pathway to manage breast reconstruction after cancer. Data from the Internal Institutional Audit including the first five-year experience are reported supporting our statements and to our knowledge is the first report describing experience of outpatient surgery for breast reconstruction.
METHODS
The study was approved by the appropriate Institutional Review Board (IRB), and written informed consent was obtained from all subjects.
We retrospectively reviewed our series of patients who underwent ambulatory surgery for breast reconstruction and refinements, analyzing outcomes related to the type of procedure, delivered anaesthesia, rate of complications and patient degree of satisfaction. Data were collected from web based DRG (Diagnosis Related Groups) system for reimbursement of public hospitals 10. A further sub-analysis of associated factors related to failure and non-compliance to the fast track program was also performed.
PATIENT SELECTION AND INCLUSION CRITERIA
During outpatient clinic different reconstructive options are discussed and selection of candidates for ambulatory surgery is performed. A printed booklet is provided to every patient for information about the type of procedure, possible risks and complications. Risk-reducing behaviors are also recommended, such as a diet regimen for weight loss, smoking or alcohol abstinence. The first clinical assessment of patients’ condition and compliance is performed at this point.
Selection criteria are based on the type of surgery, clinical, social, and logistic implications. Only surgeries not at risk of serious complications like severe bleeding or cardiovascular instability, with no or minimal expected post-operative pain and lasting less than 120 minutes were included. Complex and surgically long lasting procedures are not included in the list of outpatient approaches. The series include only delayed reconstructions while we excluded immediate procedures (Tab. I).
Candidate patients include ASA I-II, ASA III for procedures not interfering with underlying disease 11. Healthy women with a history of breast cancer, disease-free for at least 5 years, not receiving tumor related therapies and without comorbidities have been classified as ASA I patients 12-14. Advanced age, diabetes, asthma, obesity BMI < 35 and epilepsy were not considered exclusion criteria 15,16, while we excluded patients with severe and poorly controlled comorbidities, coagulation disorders, obesity with BMI > 40. Sleep apnea (requiring prolonged post-operative vigilance) is not an absolute contraindication if surgery is planned early in the morning and monitoring lasts all day long.
ORGANIZATION AND LOGISTICS
The outpatient approach is based on the sequencing of a pre-operative planning, ambulatory or “fast track” admission and post-operative surveillance. An institutional protocol regulates step by step this approach.
Pre-operative workup includes basic blood tests for all patients. An anesthesiologist and nurse’s counselling is organized for any surgery requiring general anesthesia and for patients in poor general conditions, independently of the type of anesthesia. Electrocardiogram and chest x-rays are performed if indicated 17. Patients can be switched from outpatient surgery to standard hospitalization according to the results of pre-operative evaluation. The date of surgery is then scheduled within a 30-day waiting period.
For patients in good clinical conditions undergoing sedation or local anesthesia, the pre-operative assessment is initially obtained through a home questionnaire and basic blood tests. The questionnaire investigates comorbidities, previous surgeries, allergies and drugs. Filled questionnaires and blood test results are sent back for the anesthesiologist approval. According to the questionnaire results, patients are eligible for surgery or an anesthesiologist and nurse’s counselling may be necessary for further investigations.
AMBULATORY ADMISSION
The patient is admitted and re-assessed by surgeons and nurses. Informed consent is obtained. Pre-operative drawings are marked with the patient in standing position. A pre-operative checklist to verify the clinical chart, adequate fasting, precise surgical site, and current drug therapy is reinforced (Tab. II).
The plan of anesthesia is designed in order to provide optimal surgical conditions, a rapid emergence from anesthesia, minimize post-operative pain and avoid side effects and early complications for outpatients 18.
Long fasting is not recommended 19 and patients candidate for general anesthesia are allowed to eat non-fat food until 6 hours before surgery and drink soft liquids (water, coffee, the, chamomile tea, etc.) within 2 hours.
According to clinical conditions, patients can receive atropine and midazolam 20-30 minutes prior to anesthesia to provide sedation, reduce anxiety, and optimize intraoperative hemodynamic stability 20,21.
Antibiotic prophylaxis is provided every time an implant is used, consisting of 2 grams of Cephalosporin I generation. In case of allergies, Clindamicin or Vancocyn are recommended according to hospital guidelines. For all the other procedures, not using foreign bodies and classified as clean surgeries (i.e. mastopexy/reduction, scar revision, fat grafting, nipple and areola reconstruction) antibiotic prophylaxis is not administered. Antithrombotic prophylaxis is administered in cases of intermediate or high risk of thrombosis 22. Post-operative nausea and vomiting (PONV) are managed by prophylaxis with antiemetic drugs, as dexamethasone and ondansetron 23,24.
In case of monitored anesthesia care (MAC) based-techniques, local anesthesia via infiltration is administered in combination with IV sedative-analgesic drugs (propofol, midazolam, fentanyl, remifentanyl) titrated to guarantee spontaneous ventilation and patient’s comfort and to avoid respiratory depression due to over sedation.
In case of general anesthesia, Propofol is the intravenous induction agent of choice 25. The maintenance of anesthesia is provided with either volatile anesthetics (desflurane and sevofluorane) or with total intravenous anesthesia using target control infusion 26,27. To facilitate early recovery, short-acting opioid analgesics are administered (e.g. fentanyl, remifentanil) 28. Short-acting (e.g. mivacurium) 29 or intermediate acting (e.g. cisatracurium, vecuronium, and rocuronium) neuromuscular blocking drugs are used in case of intubated patients 30. Finally, in selected patients a cerebral monitoring device (bispectral index, BIS) is used to improve the titration of both intravenous and inhaled anesthetics, facilitating the quick recovery 31.
Whenever possible, a supraglottic airway device (laryngeal mask airway) 32,33 is used as an alternative to a tracheal tube, allowing low pharyngolaryngeal morbidity and a reduced request for neuromuscular blocking drugs.
The treatment of postoperative pain is provided according to the concept of multimodal opioid–sparing analgesia 34. Acetaminophen, non-steroidal anti-inflammatory drugs and weak “atypical” opioids such as tramadol are given during the intra-operative and the post-operative course. Upon discharge, patients are usually prescribed to continue analgesia at home only with acetaminophen.
The patient is monitored for at least 2-to-4 hours after surgery according to the type of anesthesia. Discharge criteria include patient hemodynamic stability, alert consciousness, capability of dressing up by itself and walking without help, absence of bleeding, and capability to drink liquids and micturition. A minimum discharge score of 9 is required by using the modified Post-anesthesia Discharge Scoring System 35,36 (Tab. III).
Non-discharge criteria for ambulatory surgery include: non-compliance of discharge score, important post-operative complications, unexpectedly long-lasting surgery, need for re-intervention, unavailability of caregiver during the first post-operative 24 h and non-compliance of a 30-minute home to hospital travel distance. If the patient needs to be hospitalized, the medical staffs transfer him for overnight surveillance.
POST-OPERATIVE SURVEILLANCE
A complete patient compliance and a supporting familiar network providing continuous care during the first post-operative 24 hours is mandatory. Patient should also remain within a 30-minute driving distance from the hospital and should have access to a 24-hour hot line number in case of any emergency. Medical indications are clearly described in the discharge report. Both the patient and the caregiver are instructed on possible warning signs of complications during the immediate post-operative period. Home support regarding wound and drain management are reinforced through printed education booklets. An educated nurse calls the patient the evening of discharge, as well as the following morning to enhance post-operative surveillance. A follow-up office visit with the surgeon is arranged within few days after discharge.
RESULTS
4,758 patients were originally scheduled for ambulatory surgery between April 2010 and December 2014. 4373 patients (91.9%) previously underwent mastectomy for breast cancer; (65.7% nipple-areola sparing mastectomies and 26.2% total mastectomies). The remaining 385 patients (8.1%) received breast conservation. Among a total of 4.758 patients, 33 patients (0.7%) didn’t undergo surgery for temperature, vomiting and diarrhea the day of admission; they were discharged and the procedure was re-planned. In 4590 (97.2%) patients this approach was successful. Conversely, 130 patients were not discharged and further 5 patients were discharged and re-admitted, with a failure rate of 2.8%.
Patient mean age was 51 years (range 23-84).
The series include all second stage breast reconstructions and refinements. Distribution of surgical procedures was as follows: 37.8% fat grafting, 21.0% nipple-areola reconstruction, 3.2% scar revision, 19.4% mastopexies, 9.7% breast reduction, 6.3% breast augmentation, 34,8% revision/substitution of breast prostheses, 2.1% delayed reconstructions with implants, 22.1% expander replacement for prosthesis, 1.7% flap revision, 1.9% implant removal and others. There were a total of 3424 combined procedures (73%).
Distribution of cases was as follows: 570 procedures in 2010, 1075 in 2011, 963 in 2012, 951 in 2013 and 1166 surgeries in 2014.
Distribution of administered anesthesia was as follows: 69% general anesthesia and sedation (3258 procedures) and 31% local anesthesia (1467 patients). Patients treated under general anesthesia or sedation increased over time, being 44.9% in 2010, 65.5% in 2011, 75.8% in 2012, 74% in 2013 and 74.1% in 2014 (Fig. 1).
Overall the mean surgical time was 86.4 minutes. It gradually increased over time, being 74 minutes in 2010, 82 in 2011, 89 in 2012, 93 in 2013, and 94 in 2014.
Transfer to the hospital ward for standard care and monitoring occurred in 130 (2.7%) patients. The main reasons included complications detected during immediate post-operative monitoring in 123 patients (2.6%), 2 non-compliant patients (0.4%) with psychosocial issues, failure in hospital logistics in 6 patients (0.12%), and enhanced observation in 4 uncomplicated patients (0.10%) who underwent a procedure longer than expected.
Among those patients requiring standard hospitalization, a sub-analysis was performed: in 24 cases (17.7%) a single procedure was performed, and in 111 patients (82.2%) multiple procedures were involved. In total there were 117 surgeries related to implants or expanders, 60 to mastopexies, augmentation or reduction mammoplasty, there were 64 capsulotomies, 25 fat grafting, 19 nipple areola reconstructions, 7 scar revisions, and 19 were classified as other procedures. Mean surgical time was 67.9 minutes (range 23-161). There were only 2 (1.5%) procedures performed under local anesthesia, 7 (5.2%) under local anesthetic and sedation, and 126 (93.3%) in general anesthesia.
Associated complications and several reasons for failure were observed. There were 70 (1.5% of the all patients undergoing ambulatory surgery) patients who presented at least one of the following symptoms: pain, nausea, emesis, or adrenergic symptoms including diaphoresis, hypotension, asthenia and vertigo. There were 41 (0.9%) patients with some degree of bleeding or hematoma requiring surveillance or surgical drainage, 3 patients presented rash or an allergic drug reaction, 3 patients had hyperthermia, and 6 patients had other complications. Five patients without complications were transferred to the ward for failure in logistics or surgery performed late in the evening requiring an adequate postoperative monitoring. There were two uncomplicated non-compliant patients who stayed in the hospital overnight, one because of anxiety and the other because of lack of family support.
In total there were 17 (0.3%) surgical revisions associated with bleeding or hematoma, 117 (2.5%) complications managed with medical treatment and enhanced monitoring, and 1 invasive procedure related to a bronchoscopy performed to remove a foreign body (tooth) in the airway. Four patients (0.08%) were discharged and readmitted within a period of 24 hours (range 12-24). Three of these patients suffered from bleeding or hematoma. It was conservatively managed in 2 patients and surgical drained in one patient. Another patient was readmitted for hyperthermia. A further patient was readmitted 14 days after discharge for a chronic retro-implant hematoma surgically evacuated.
DISCUSSION
Henrik Kehlet first introduced the “fast-track surgery” concept in Denmark during 90’s 37. The aftermath of his vision was the introduction of a coordinated perioperative approach to strategically reduce surgical stress and organ dysfunction and to facilitate postoperative recovery 4-6.Problems concerning post-operative nausea, vomiting (PONV) and pain have been described as the main causes for a prolonged hospital stay as well as the absence of psychosocial support and the lack of a comprehensive tutorial for the homecare of wounds and drains 7.
Over the years, the concept of fast track has been implemented in many fields of surgery and quantitative analysis from randomized trials and cohort studies suggest that it is effective in reducing hospital stay without increased adverse events 4,7-9.
In 2002 Dooley et al. 5 reported their simplified model for ambulatory breast cancer care. In 2013 Bonde et al. 6 showed that the length of stay after free flap breast reconstruction could be reduced without increasing complication rates or flap loss.
The trend towards conservative surgery for breast cancer during the last decades has strongly contributed to the promotion and feasibility of ambulatory surgery and breast reconstruction surely represents a potential field. In fact, more conservative surgeries for cancer treatment require less invasive procedures for reconstruction. Moreover, patients request multiple refinements to achieve satisfactory cosmetic results. Therefore, the ambulatory approach represents the ideal pathway for several consecutive surgical procedures. In our experience, the introduction of a coordinated peri-operative approach allowed the shift from standard hospitalization to ambulatory recovery for several procedures in fit patients. Before 2010, the majority of these procedures required a standard hospitalization of 3 to 4 days, nowadays more than 93% of all reconstructive delayed procedures are delivered in ambulatory surgery.
A study group was initially set up to create the organization and logistics supporting the project before implementing ambulatory procedures. Medical doctors, nurses and administrative personnel joint the group over one year. The meetings were monthly scheduled. In fact, we do believe that the successful implementation of ambulatory surgery requires braking paradigms on hospital logistics, interdisciplinary collaborations, identification of culture barriers, education and strong leadership from involved doctors and nurses, changing in the mindsets of patients and health professional 4,5,9. Standard outpatient protocols were created with clear clinical pathways for patients 4,7.
In our opinion, patient selection as well as preoperative clinical and risk assessment is critical to success. This allows the team to accurately map patient pathway and identify problems to proactively manage them 4. Smoking cessation three weeks prior to surgery is advised as it has proved to reduce the incidence of cardiorespiratory complications, bleeding, wound infections, and wound dehiscence 4. Breast care nurses play a pivotal role in providing information, counseling and support 4,9. Early post-operative management should include prompt mobilization, early feeding and multimodal opiate-sparing analgesia 6.
We do not recommend long fasting for general anesthesia or sedation since many studies have demonstrated that avoiding fasting-induced dehydration is both safe and effective in reducing post-operative side effects 38.
Anesthesiologists surely play a key role in ambulatory surgery through their choice of pre-operative medication, anesthetic techniques, and prophylactic drugs to minimize side effects. The administration of adjunctive drugs to maintain major organ system function during and after surgery is essential 39. Several surgical procedures are performed in our experience with monitored anesthesia care techniques. It has proved that they facilitate a fast recovery after surgery and are associated to a low incidence of post-operative side effects, allowing patients to be discharged earlier 40,41. The reasons for choosing general anesthesia versus monitored anesthesia care are influencing by the extent of surgery and patient compliance.
An adequate post-operative analgesia is mandatory too. Several studies have shown that 30 to 40% of patients suffer from moderate to severe pain during the first 24-48 hours 42,43. As well as PONV, post-operative pain is the most common reason for delayed discharge. We do suggest a multimodal opioid-sparing analgesia, achieving synergistic analgesic effects and reduced drug-related side effects 37,44,45. Our data, including only 1.5% of the all patients presenting pain or nausea/emesis or hypotension, asthenia and vertigo, demonstrate the effectiveness of our protocol of pain control. Moreover, it has been demonstrated that poorly managed post-operative pain is considered one of the most important predictive factors for chronic pain. The incidence of chronic pain after ambulatory procedures such as breast surgery may be above 50% 46.
With regards to failure of hospital discharge (2.8%), it happened mainly in cases of general anesthesia (93.3% of failures) rather than local anesthesia (5.2%) and pure local anesthesia (1.5%). General anesthesia can be considered a risk factor for failure since it is generally associated to more extensive surgery and prolonged procedures, therefore increasing the risk of surgical complications such as bleeding and prolonged post-operative recovery. In our planning, we usually schedule procedures requiring general anesthesia in the morning and local anesthesia in the afternoon to facilitate postoperative recovery from anesthesia.
Our experience demonstrates that the implementation of ambulatory surgery can be safe and without increased number of complications, re-admissions, re-operations or visits to the emergency department, as described in the literature 8,9. Moreover, improvements in logistics have resulted in the inclusion of more complex cases, as demonstrated from longer surgeries included in the program during this 5-year experience and the increased number of procedures performed under general anesthesia. Nowadays we feel very confident with ambulatory surgery, planning even more complex surgeries and several combined procedures.
One of the main benefits of this approach is patient satisfaction, which is very high in the vast majority of cases. Since our first experience, we are collecting back patients’ questionnaires to refine and improve the process. Patients know through their satisfaction survey that observations and suggestions can directly impact and improve the care of subsequent patients. Furthermore, current challenges include addressing the quality of care not only through healthcare certification committees, but also through our patient’s own degree of satisfaction 5.
Finally, this approach may have a positive impact on productivity and cost-efficiency, with positive financial benefits. Although ambulatory surgery was introduced solely to improve quality of care and no systematic cost-effectiveness analyses were conducted, we could increase the number of patients treated. In fact, reducing hospital stay, we could expand our activity beyond the limitation of bed availability. In the past we were planning the same surgical procedures with a mean hospital stay of 2-4 days. Nurses working by night were dedicated to counselling and surveillance. Moreover, closing down the ward during weekends has led to a reduction in costs (weekend pay of medical staff and nurses).
Our study presents several limitations. Its retrospective nature since data were collected from web based DRG (Diagnosis Related Groups) system for reimbursement of public hospitals. Therefore, some data may have been missed, i.e. those concerning readmission for complications after two-three days-a week if the patient didn’t come to our hospital but referred to other hospitals.
Secondly, we lack a control group of patients undergoing traditional “long lasting” hospitalization for the same extent of surgery. We acknowledge that our study is based on the assumption that fast track surgery is not only more patient-friendly but also cost-effective.
Finally, our primary objective was to validate the sustainability of fast track surgery and to identify the target of this approach. Further studies are warranted to assess patient satisfaction through dedicated questionnaires.
In conclusion, our experience clearly shows that ambulatory surgery, when carefully planned and monitored, can be safely performed and has significant clinical, fiscal and other patient benefits over in-hospital care. A detailed study of the process as well as patients’ and personnel education is mandatory to reach this goal.
CONFLICT OF INTEREST STATEMENT
The authors declare no conflict of interest.
FUNDING
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. None of the authors received any funding for this work from any of the following organizations: National Institutes of Health (NIH); Wellcome Trust; Howard Hughes Medical Institute (HHMI); and other(s).
AUTHOR CONTRIBUTIONS
FD: A, DT, W
AVEL; CG: W
GFM, AG: DT
AT, DD, PL, BB: D
MR, PV: A
Abbreviations
A: conceived and designed the analysis
D: collected the data
DT: contributed data or analysis tool
S: performed the analysis
W: wrote the paper
O: other contribution (specify contribution in more detail)
ETHICAL CONSIDERATION
Not applicable.
Figures and tables
Figure 1. Distribution of type of anaesthesia in the interval time.
| Fast-track procedures | Type of anaesthesia |
|---|---|
| Fat grafting | local/sedation |
| Nipple-areola complex reconstruction | local |
| Scar revision | local/sedation/general |
| Mastopexy | local/sedation/general |
| Breast reduction | sedation/general |
| Breast augmentation | sedation/general |
| Revision of breast prosthesis/implant change | sedation/general |
| Breast expander replacement for prosthesis | sedation/general |
| Capsulotomy/capsular revision | sedation/general |
| Liposuction | local/sedation/general |
| Flap revision | local/sedation/general |
| Combined procedures (more than one of the above mentioned) | local/sedation/general |
| Surgical planning patient awake | Phase 1: informed consent verification |
| Phase 2: surgical site verification | |
| Phase 3: clinical chart verification | |
| Timeout; patient with anaesthesia | |
| Phase 4: time-out before starting surgery | |
| Verification of patients’ personal data | |
| Availability of required medical equipment | |
| Adequate position of the patient | |
| Verification of surgical site | |
| Verification of surgical indication |
| Vital signs blood pressure, pulse rate, temperature, pulse-oximetry | |
| 20% above pre-operative measures | 2 |
| 20-40% above pre-operative measures | 1 |
| > 40% above pre-operative measures | 0 |
| Activity | |
| Safe ambulation, no dizziness | 2 |
| Ambulation, help needed | 1 |
| Unsafe ambulation, dizziness present | 0 |
| Nausea and vomiting | |
| Mild | 2 |
| Moderate | 1 |
| Severe | 0 |
| Pain | |
| Mild | 2 |
| Moderate | 1 |
| Severe | 0 |
| Bleeding | |
| Mild | 2 |
| Moderate | 1 |
| Severe | 0 |
| Micturition considered only when risk factors for urinary retention are present | |
| Spontaneous | 2 |
| Present under stimulus | 1 |
| Absent under stimulus | 0 |
| Total score | |
| Nurse in charge | |
| Surgeon in charge | |
| Anaesthesiologist in charge | |
| Date & hour | |
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