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a Department of General Thoracic Surgery, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain
b Department of Anesthesia, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain
c Department of Anesthesia, Azienda Ospedaliera Careggi, Firenze, Italy
Accepted for publication October 16, 2009.
* Address correspondence to Dr Macchiarini, Department of General Thoracic Surgery, Hospital Clinic, University of Barcelona, Villarroel 170, Barcelona, E-08036, Spain (Email: pmacchia{at}thoraxeuropea.eu).
Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.
| Abstract |
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Methods: This was a prospective, clinical feasibility study. Patients with upper tracheal stenosis were managed through cervical epidural anesthesia and conscious sedation, and atomized local anesthetic. No intraoperative intubation or jet ventilation was required. Outcome measures were ease of surgery, observer-rated functional result, early (less than 30 days) complications, and patient-reported satisfaction.
Results: Twenty consecutive patients with idiopathic (n = 4) or postintubation (n = 16) complete (n = 3) or severe (>80%, n = 17) subglottic (n = 12) or upper trachea (n = 8) stenosis were enrolled. Operations included 12 subglottic and 8 segmental resections with primary anastomosis. Permissive hypercapnia was well tolerated. Median length of resection was 4.5 cm (range, 2 to 6 cm), and 12 releases (8 thyrohyoid, 4 suprahyoid) were required. One patient required a nasotracheal tube for 36 hours. All but 1 were able to cough and talk immediately, and to swallow fluids and solids, and were fully mobilized at 6 hours. There were no early complications. Median hospitalization was 3.1 days (range, 2 to 15). Patients had excellent (n = 16) or good (n = 4) functional (n = 20) outcomes, with no early relapse of stenosis. Median self-reported satisfaction at median 12 months was 9.5 ± 1.0 (scale, 0 to 10). All patients indicated that they would be happy to repeat the procedure.
Conclusions: Awake and tubeless upper airway surgery is feasible and safe, and has a high level of patient satisfaction. If supported by randomized controlled trial, this method will change the way airway stenosis surgery is approached by both surgeons and anesthesiologist.
| Introduction |
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Cervical epidural anesthesia (CEA) has been used for many different surgical procedures of the cervicothoracic median and lateral anatomical compartments, for example, carotid endarterectomy [2, 3], thyroidectomy [4], mastectomy [5], and shoulder or hand [6–8] surgery, as well as for postoperative rehabilitation after hand/shoulder surgery [9] and chronic pain therapy [10]. Cervical epidural anesthesia may eventually provide an alternative method to general anesthesia for upper airway surgery. In effect, because it blocks the brachial (C5 to T8) and cervical superficial plexus (C1 to C4), depending on volume and concentration of the local anesthetic [11], patients would be completely painless but under spontaneous respiration. That would eliminate not only the need of tracheal intubation or intrafields tubing but also would facilitate both surgical reconstruction and eventually patient recovery. To evaluate the clinical feasibility of CEA for upper tracheal surgery, we performed the present prospective clinical evaluation, and results are presented.
| Patients and Methods |
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Patients were contacted by telephone and were administered a follow-up questionnaire to assess subjective responses to surgery. Follow-up study questionnaires used Likert scales (ratings 1 to 10) to describe preoperative and postoperative symptoms, satisfaction, and perceived effectiveness [12]. A score of 0 signified extreme dissatisfaction or ineffective therapy, whereas a score of 10 signified extreme satisfaction or effectiveness. The Institutional Review Board at the Hospital Clinic Hospital approved the study protocol.
Anesthetic Technique
All patients were premedicated with 1 mg midazolam and 0.1 mg/kg atropine intravenously. Patients were first placed in a sitting position and with a slight neck flexion. Under aseptic conditions and under local anesthesia with 2% lidocaine, an epidural catheter was inserted between the C7-T1 vertebral interspace, using a 18G Tuohy needle directed cephaled and a low resistance syringe by loss of resistance and hanging drop methods to localize epidural space. An epidural disposable catheter 18G was introduced cephalic 3 cm, and a test dose (2 mL) of 2% lidocaine was administered. Thereafter, patients were placed in the supine position and monitored as follows: electrocardiogram, pulse oximetry, invasive arterial blood pressure and gases, and bis-spectral index, the latter being part of standard monitoring in our institution. The surgical position was sitting at 30 to 45 degrees and with dorsal neck flexion. At this time, sedation with low doses of remifentanyl at 0.05 µg · kg–1 · min–1 to 0.1 µg · kg–1 · min–1 and a 40% to 50% oxygen face mask were applied. Cervical epidural anesthesia was obtained by the administration of fractionated doses of 0.5% ropivacaine, from 6 mL to 8 mL, given in a fractionated manner every 10 minutes.
Anesthesia level was tested by pin-prick sensation. If the anesthesia level was insufficient, a further dose of 2 mL of 2% lidocaine was given, and the surgical field was atomized with 2% or 40 mL mepivacaine using a special catheter designed to atomize local anesthetic to skin or mucosa. Mepivacaine was given because it has long duration and in all patients, independently of the CEA block. Additional doses (2 mL) of 0.5% ropivacaine were eventually given 1 hour thereafter, if necessary.
Surgical Technique
At the time of skin incision, 2 mL to 5 mL 2% lidocaine were infiltrated in the cervical incision area. Dissection was then made as usual, taking care to respect all the basic guidelines of airway surgery. Before opening the pretracheal fascia or performing an upper median sternotomy, the surgical area was abundantly atomized with 2% mepivacaine to prevent cough from the introduction of the finger into the mediastinum. Once dissection was completed, patients were informed that the airway was divided and they could no more use their voice during this phase. The trachea was then opened, and the patient allowed to breathe spontaneously. If peripheral arterial oxygen saturation was less than 90%, then a small nasogastric tube was placed into the distal airway, delivering 5 to 6 L oxygen per minute (apnoic hyperoxygenation).
All patients were treated with a single-stage laryngotracheal resection with primary end-to-end anastomotic reconstruction, according to our previously described techniques [13, 14], but without intraoperative tubing systems. No chin sutures were placed. In patients whose reconstructions were within 1 cm from the vocal cords, injection of 2 mL of steroids under direct vision was done on the lower surface of the vocal cords to prevent perioperative edema just before completing the anastomosis. At the end of surgery, the epidural catheter was removed after administration of a 3 to 4 mL of 0.2% ropivacaine for postoperative analgesia, perfusion of remifentanyl was stopped, and patients were transferred to the recovery room. The cervical epidural was removed after surgery and was not planned to use for pain control because (1) the intervention is not a very painful, and therefore pain can be managed with intravenous analgesia; (2) there is a potential risk of leaving an epidural catheter at the cervical level; and (3) the intensive care unit nursing staff lacked experience with cervical epidural catheters.
Postoperatively, and within 6 hours, patients were allowed to cough, swallow fluids and semisolids, and speak, and were fully mobilized. After 12 hours, patients were transferred to the normal ward, and standard pain care was given if necessary.
Statistical Analysis
Data are presented as mean ± SD, absolute numbers or percentages. All values were calculated and tested using SPSS 7.0 (SPSS Inc, Chicago, IL). The paired sample t test was used to compare means before surgery and at follow-up, and differences were considered significant at a 95% level (p < 0.05). The anatomic and functional criteria used postoperatively to assess outcome were expressed as excellent (without any sequelae), good (minor sequelae not affecting quality of life), satisfactory (patients are stressed on exercise, with abnormal vocal cords and narrowed anastomosis), or failure, both anatomically and functionally [13, 14].
| Results |
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| Comment |
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Contraindications for the technique per se are the same as those for epidural anesthesia at the thoracic or lumbar level, and include allergy to local anesthetics, blood coagulation alterations, anticoagulation therapy, and contraindications to sympathetic blockade (congestive heart failure and severe aortic or mitral stenosis). In our series, we excluded only 1 of 21 patients (5%) with a subglottic tracheal stenosis due to prolonged tracheal intubation after mechanical mitral valve prosthesis that was receiving acenocumarol (Coumadin). No hemodynamic complications due to CEA block were observed in our patients, and we may speculate that the nature of the local anesthetic used for CEA in these patients may have contributed to the absence of such complications. In effect, ropivacaine is an amida-type local anesthetic like bupivacaine but with much less central nervous and cardiac toxicity, and has induces a differential block, with a more pronounced sensory than motor block, at least at the concentrations used in our patients (as high as 0.5%). High epidural block can decrease heart rate by blocking sympathetic heart innervations, so that administration of atropine is mandatory during CEA. Cervical epidural anesthesia may induce some changes in pulmonary function. Some studies [15, 17] using CEA with bupivacaine demonstrated a decrease in diaphragmatic function and tidal volume and an increase in respiratory rate, thus unchanging minute ventilation; in that experience, oxygen saturation values as measured by pulse oximetry (SpO2) decreased after CEA as a result of ventilation-perfusion mismatching in basal pulmonary regions due to atelectasis formation. In our series of CEA with ropivacaine, SpO2 was well maintained although, as expected, patients had a tendency to hypercapnia during the procedure.
Patient acceptance and collaboration is, of course, necessary to perform any intervention under locoregional anesthesia. To make the procedure more comfortable for the patients, a low dose of midazolam (1 mg intravenously) was given before epidural catheter insertion and sedation with a continuous infusion of very low doses of remifentanyl (0.05 to 0.1 µg · kg–1 · min–1) was administered from beginning to end of surgery to reduce patient anxiety. The level of sedation was very low, allowing verbal contact between patient and anesthesiologist and operating surgeon. No patients complained of feeling any discomfort during the procedure.
The main advantages of CEA for upper tracheal surgery are several. First, it guarantees good sensory block that provides adequate level of anesthesia while avoiding general anesthesia, tracheal intubation, and mechanical ventilation and its related complications. Second, it provides ideal surgical conditions without any intraoperative tubing systems, speeding up, if necessary, the procedure. Third, the maintenance of spontaneous breathing makes airway reconstruction more anatomical, for example, the inspiratory and expiratory movements allows the surgeon a better and individual appreciation of the length of resection to be tolerated; that the patient can move the vocal cords allows surgeons to control their movement and, in our opinion, to get closer to the vocal cords. Fourth, it affords the possibility to communicate verbally with the patient during and immediately after surgery. And last, but not least, it permits early patient recovery (cough reflexes are not aborted), mobilization, and oral intake. Our high percentage of edema of the vocal cords may be related to our operating closer to the vocal cords, probably higher than we would have done if patients were under general anesthesia. In a given sense, that means that we could resect more length because of the intraoperative direct control and visualization of the vocal cord from below.
In conclusion, we provide clinical evidence that airway surgery is feasible in awake patients under cervical epidural anesthesia and spontaneous breathing, and that this surgery not only avoids general anesthesia with tracheal intubation and mechanical ventilation but also improves patients recovery. The procedure has a high level of patient satisfaction. If supported by a randomized controlled trial, this method could change the way airway stenosis surgery is approached by both surgeons and anesthesiologists.
| Discussion |
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DR MACCHIARINI: Exactly, we see how they cough, how they do. And usually a suprahyoid release does not need to be a complete release, so you just have to eventually cut the median part to gain some centimeters, which is more than enough in my opinion. You don't need to touch the superior or recurrent nerves or the nerves that are responsible at the cricoesophageal level for the motility.
DR PAULO F. G. CARDOSO (Porto Alegre, Brazil): That's quite a paradigm shift for me. We have been doing cricopharyngeal diverticula and thyroidectomies under local, but I have never conceived anything quite like that.
I have a couple of questions for you. First, in patients who have had tracheostomy previously, would you proceed the same way in this tubeless and awake fashion? Second, in case a suprahyoid release is required, would you consider using the same incision, just prolonging it, or would you perform a second incision? Third, how much local anesthetic do you have to use for these patients?
DR MACCHIARINI: The local anesthetic is not that much. It depends on the sensibility of the patient, because in this case we were using local anesthesia with a more sensitive profile, and so it's blocking the sensations, sensibility receptors and not the motility receptors.
The second question was if we do a second incision. The incision is very minimal, 4 cm, nothing more, and we will do our best to perform whatever release through the same incision. The first question was?
DR CARDOSO: The tracheostomy.
DR MACCHIARINI: One of the patients was a lady with a tracheal cannula, so in this case, what happens is that you need to look at exactly how big, how large the tracheal stoma is and whether or not the lady has a supracannula complete occlusion. If the stoma is very small, then she probably will never be able to breathe, so you leave the tracheal stoma there, but you can test that before doing surgery. If it is okay, then you take it off. If not, you do surgery.
DR ROBERT J. CERFOLIO (Birmingham, AL): But what happens if you get close to your toxic dose of lidocaine but still have more work to do? Has that happened to you?
DR MACCHIARINI: No.
DR CERFOLIO: And if it does?
DR MACCHIARINI: We'll see. [Laughter.]
DR MICHAEL LANUTI (Boston, MA): Doctor Macchiarini, this is a commendable effort, but I struggle with this approach a little bit.
I have one philosophical and two technical questions. One, what was the impetus to go ahead and attempt this approach? What were the mechanical aspects of the traditional open approach to tracheal resection and reconstruction using general anesthesia that were dissatisfying to consider this technique?
DR MACCHIARINI: I thank you so much that you are asking that. Mr Grillo, I met him several times in my life, you know that, and one of the times was in 2004 in Italy, and we were eating and, well, drinking, and you know how he loved good wine and good grappa. So after at least seven glasses of grappa, he said, "Paulo, what do you think about spontaneous respiration in airway surgery?" I answered, "Well, it's a wonderful thing, but I've never picked up a good anesthetist that would eventually do that." It is the most physiological way to do an airway operation. You don't ventilate the patient. So starting from there, I wanted to see if it was possible. If you look, you will find, and finally, 6 months after, I found one, and then all the history starts. I think compared with the normal general anesthesia, you have a lot of advantages, especially for the patient. Not having a tubing system that interferes with the surgery is something wonderful. In experienced hands like yours, the surgery can be reduced. And I remember the hospitalization stay from your group on subglottic resection presented at the STS last time was 1.3 days. This was 3 days. So that's even another reason.
DR LANUTI: The airway is open. The respiratory effort is depressed with your regimen. Do you insufflate the field with oxygen? Do you increase the O2 tension in the room? How do you keep the patient's oxygen saturation up? I didn't see any supplemental oxygen given across the field.
DR MACCHIARINI: Yes, correct. You don't need to. The only thing that you need to do is to ask the patient to stay awake. Sometimes they sleep, so you just have to wake them and say, "Please breathe deeply," and you will see that the trachea moves and takes oxygen from below.
| References |
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M. R. Katlic and M. A. Facktor Video-Assisted Thoracic Surgery Utilizing Local Anesthesia and Sedation: 384 Consecutive Cases Ann. Thorac. Surg., July 1, 2010; 90(1): 240 - 245. [Abstract] [Full Text] [PDF] |
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