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Ann Thorac Surg 2003;76:1009-1015
© 2003 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, George Washington University Medical Center, Georgetown University Medical Center, and VAMC, Washington, DC, USA
* Address reprint requests to Dr Alexander, Cardiothoracic Surgery, 2150 Pennsylvania Ave, Suite 6B, Washington, DC 20037, USA.
e-mail: ealexander{at}mfa.gwu.edu
Presented at the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 2830, 2002.
| Abstract |
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METHODS: From January 1995 to December 2001, 179 patients underwent VATS lobectomy for preoperative stage I lung cancer (T1N0, 118 patients; T2N0, 61 patients). Mean age was 64.34 years (range, 38 to 87); 91 were female and 88 were male. Contraindications to VATS lobectomy included any suggestion of hilar, endobronchial, or central lesions. Video-assisted thoracic surgery lobectomy was performed using three ports, partial anatomic hilar dissection, and mediastinal node dissection.
RESULTS: Distribution of lobectomies was as follows: left upper lobe, 50 patients; left lower lobe, 27 patients; right upper lobe, 33 patients; right upper and right middle lobe, 29 patients; right middle lobe, 9 patients; right lower lobe, 30 patients; right middle lobe and right lower lobe, 1 patient. Mean operative time was 75 ± 6 minutes. Mean lymph node yield was 11 ± 5 nodes. Pathologic upstaging was noted in 14 of the 179 patients (7.8%). Mean hospitalization was 4.1 days (range, 2 days to 4 months). There were no conversions to thoracotomy and there was 1 death (1 of 179, 0.05%). Complications included air leak in 24 of 179 (13.4%), subcutaneous emphysema in 4 of 179 (2.2%), pneumonia in 10 of 179 (5.6%), wound infection in 5 of 179 (2.8%), respiratory failure in 3 of 179 (1.7%), pulmonary embolism in 2 of 179 (1.1%), and myocardial infarction in 1 of 179 (0.5%). At a mean follow-up of 37 months, local recurrence rate was 0.013 per person per year. Actuarial recurrence-free survival was 88% and 85% at 36 and 60 months respectively.
CONCLUSIONS: For carefully selected patients VATS lobectomy for early stage lung cancer is a safe and effective strategy. Long-term follow-up is required to fully evaluate recurrence and survival.
| Introduction |
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This report describes an alternative procedure using hilar control with multiple discrete staple firings and the use of visceral pleural support for staple lines. No access minithoracotomy or utility thoracotomy is performed. The technique, safety, and outcome of this procedure with particular attention to incidence and pattern of treatment failure and its consequent oncologic effectiveness are described.
| Patients and methods |
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There were 91 women (91 of 179, 50.8%) and 88 men (88 of 179, 49.1%) ranging in age from 38 to 87 years (mean, 64.34). Preoperative clinical stage was stage IA (TIN0) in 118 of 179 patients (66%) and stage IB (T2N0) in 61 of 179 patients (34%).
Operative technique
The surgical technique for VATS lobectomy employed in this series was originally developed and tested in animal and cadaver models. The overall intent was to develop a procedure that had the simplicity and reproducibility of VNSSL but approached standard anatomic lobectomy in terms of the minimal volume of lobar hilar tissue left in situ and additionally avoided the use of a utility thoracotomy.
Equipment and personnel are positioned in a manner similar to other VATS procedures. One-lung ventilation is used and the patient is placed in a lateral decubitus position. Three 2-cm incisions are made using a nontrocar technique. The videoscope is placed in the eighth intercostal space in the midaxillary line. Additional incisions are placed typically in the fifth intercostal space posteriorly and sixth intercostal space anteriorly. If histologic confirmation is required a biopsy is performed using a Microvasive Trucut needle (Boston Scientific, Watertown, MA). Exploration of the hilum and partial dissection of the vascular and bronchial structures is performed. The N1 nodes are identified and sampled, after which fissures are developed and additional nodes are sampled. The lobe is retracted and a tactile clamp is used to delineate the location and edges of the vessels and the bronchus. The tactile clamp is subsequently used to guide positioning of the Ethicon EZ-45 (Ethicon EndoSurgery, Cincinnati, OH) endostapler. Visceral pleura is used as an anatomic pledget in order to distribute the torque that occurs with stapler firing. The clamp and stapler are positioned and repositioned across the pulmonary vein and bronchus typically parallel to the pulmonary artery except in the case of the middle lobe where the structures travel together. The pulmonary vein is stapled separately in lower lobe lobectomies after dissection of the inferior pulmonary ligament. Bilobectomies were performed in the setting of an incomplete fissure and a lesion near or crossing the fissure peripherally. The lobectomy specimen is placed in a lubricated endoscopic specimen removal bag, which is used to avoid contact with the chest wall tissues and possible inoculation metastases. After the lobectomy a full mediastinal dissection is performed with removal of subcarinal, paratracheal, paraesophageal and inferior pulmonary ligament lymph nodes as appropriate. For postoperative analgesia intercostal cryolesions are placed adjacent to each of the three access incisions.
Follow-up
Length of postoperative stay, all major and minor complications, and mortality were recorded for each patient. Follow-up was obtained from records of post discharge visits, interviews, tumor registry data, and regular radiographic follow-up. Computed tomographic scans of the chest were obtained in most patients at 6, 12, 18, and 24 months postoperatively and thereafter at yearly intervals. Eleven patients who were asymptomatic did not have CT scans postoperatively. They are included in the survival but not in the recurrence analysis.
In the evaluation of pattern of treatment failure, diagnosis of recurrent disease required radiographic and pathologic confirmation. Recurrence was defined as local when disease recurred at or near the primary site, pulmonary hilum, or in bronchopulmonary and local mediastinal lymph nodes. Recurrence was defined as distant when disease developed in a separate lobe or the contralateral lung in addition to remote metastatic disease. Recurrence was defined as local and distant when tumor deposits were identified simultaneously in these areas at the time of initial detection of treatment failure. Distinguishing second primaries from distant recurrence was frequently difficult. These cases were recorded as distant recurrences unless specific criteria were met [18].
Statistical analysis
Survival and recurrence free survival were measured from the date of surgery to the date of death, diagnosis of recurrence, or the date of most recent follow-up. Recurrence was expressed both as an absolute percentage and per person per year. Actuarial survival and recurrence-free survival were calculated using the Kaplan-Meier method and comparisons made using the log rank test. The
2 test and Fishers exact test were used to test whether relationships existed between nominal variables.
| Results |
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Seventy-three complications were observed in 37 patients and are noted in Table 4. Air leak for longer than 4 days was the most common problem; 3 patients were ultimately discharged with chest tubes in place. Wound complications occurred predominately in the early part of the series before a change in access incision closure with the adoption of an interrupted muscular and skin closure.
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| Comment |
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Successful VATS lobectomy without a utility thoracotomy is dependent on enabling instrumentation and the development of a hybrid technique, with some features of isolation ligation and some features of simultaneously stapling. The technical approach in this series exploits the view of the lobar hilum from the cephalad perspective of an inferiorly placed camera looking up the completed major fissure. The avoidance of a utility thoracotomy may further achieve the goal of making lobectomy less invasive.
Complications have generally been manageable with this technique and the procedure is well tolerated in most patients. Air leak and its associated problems have been the most common problem and have been addressed in several different ways. Postoperative air leak was initially managed with talc pleurodesis. More recently we have applied Focal Seal-L (Genzyme Biosurgery, Cambridge, MA), an absorbable polymer that is fixed by blue light and is applied intraoperatively to staple lines [24]. This material has virtually eliminated postoperative air leaks. Several technical developments have avoided the bleeding problems and consequent conversion to thoracotomy that are pitfalls of VATS techniques [25]. These include use of visceral pleura to buttress staple lines, routine use of vertically apposed staplers, and expertise in extracorporeal knot tying with fine suture.
To fully establish a lessened physiologic impact and oncologic equivalence or superiority for VATS lobectomy, longer follow-up of this and other series is required. Additionally, a prospective randomized controlled trial comparing VATS lobectomy with conventional open lobectomy is warranted.
| Discussion |
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The biggest questions I have about this paper relate to technique. As was presented this morning, the author describes leaving the pleura intact over the pulmonary artery. Fifty years have passed since we did a tourniquet lobectomy, and to me the standard of practice in the community has been the individual ligation of the artery, the vein, the bronchus, and the fissure. I do not understand how it is possible to take out those N1 lymph nodes along the pulmonary artery, leaving the pleura intact over the pulmonary artery.
Last year 15% of the lobectomies that we did had N1 lymph nodes. So when you are not taking out those N1 lymph nodes, it seems to me that this operative approach is a compromise operation for the patients that have stage II lung cancer. In addition looking at the types of procedures that were done, last year we did 48 VATS right upper lobectomies, there were 2 bilobectomies, taking out the middle lobe and the upper lobe. In the series that was presented, there were 33 right upper lobes and 29 right middle and right upper lobes. So I do not understand the reason for so many bilobectomies, and I wonder if it has something to do with the operative technique. It is likely that this technique resulted in the unnecessary removal of several lobes.
The bottom line to any operation is survival, so with a large series of patients, if this operation turns out to have the same survival for patients and lower morbidity and mortality, then it would be reasonable to take this approach. But it seems to me that this is still a significant leap from the current community standard of practice to individually ligate the artery, the vein, the bronchus, the fissure, and do the lymph node dissections.
DR TODD L. DEMMY (Columbia, MO): I rise to congratulate you on this large series. I also have a technical question as it relates to the patients morbidity. I presented a paper for a series of patients with high-risk characteristics for VATS lobectomy, thinking that for this particular group the minimally invasive approach might provide an advantage as far as complications. I was curious whether your experience represented mostly low-risk patients because when viewing your video, the lung seemed to collapse very well.
When you take a high-risk group of patients with poor FEV1s, which is perhaps more common in our practices, the lung does not quite collapse as well and that utility thoracotomy becomes very important because you can look through it and divide the fissure between the upper and middle lobes under direct vision. That allows you to then expose the pulmonary artery after you have taken that fissure and divide the formerly obscured branches from the pulmonary artery to the remaining upper lobe.
So my question is, do you think that not having that access thoracotomy is what led to the higher number of combined bilobectomies on the right side and do you think that you could have pulled the lungs with more fibrosis and chronic obstructive pulmonary disease out through your 2-cm thoracotomy port?
DR GHARAGOZLOO: Let me start by speaking about the combined upper and middle lobectomies. I completely agree with Dr McKenna that the numbers are much higher than we would expect with an open procedure. There are multiple reasons for that. The most important reason is technical, as he determined.
Early on in the series we found that when individual middle lobectomies or upper lobectomies were performed, we saw 1 or 2 patients who had early recurrence and we felt that that was a problem with the procedure. It is difficult to get the N1 nodes that lie between the middle and upper lobe, and for technical reasons we have felt that we would probably have a better cancer operation with a combined operation, especially in those patients where the lesion is close to the fissure between those two lobes.
As far as the N1 nodes are concerned, in the beginning of the procedure we do try to dissect the N1 nodes as we complete the fissures. Undoubtedly there will be N1 nodes that are left behind, and I think only a long-term follow-up with a prospective study will tell us the importance of this when it comes to the efficacy from an oncologic standpoint.
As far as which patients we selected, early in the series only patients who were not candidates for a number of different reasons for open procedure actually underwent this procedure. In emphysematous lungs, by placing a suction catheter to the double-lumen endotracheal tube and compressing the lung, one can actually decompress that emphysematous lobe quite well; removal actually depends on the use of the pneumobag, as it was described in the slide presentation. This is a homemade situation; it is made in-house at our institution. There are two bags, one inside the other, with lubricant in between the two bags. Any size lobe can be placed inside the inner bag and the outer bag is used to protect the incision from inoculation metastases, and the specimen is then withdrawn with ease because of the lubrication. I do not think that the size or the degree of emphysema in the lobe has been a problem to this day.
DR SCOTT SWANSON (New York, NY): I had a question about quality of life. We just finished a CALGB intergroup study that shows the operation is feasible in a multi-institutional setting. We are currently constructing a phase III study, and one of the key questions is whether there is a benefit. With your survival notwithstanding, I think most of the benefit will be in terms of functional outcome, quality of life, pain, etc. Did you look at that in your study?
DR GHARAGOZLOO: Yes, we have. Our VATS program has been a multidimensional program. I think that for this procedure or for VATS in general to be successful, quality of life is very important. One part of this procedure, which has been reported on elsewhere and will be in the future, has to do with pain control. We use cryoanalgesia of the intercostal nerves. We have found that in the later portion of our series when we have used the cryoanalgesia, the patients have a significant decrease in pain, and in fact our hospital stays are now in the range of 2 to 3 days on a median. I think that one has to have a multidimensional approach to this in order to make the quality of life better and also not lose sight of the fact that there needs to be oncologic efficacy for the operation.
If I can make a comment about one of Dr McKennas ques-tions, which I did not comment on, and that was the use of the visceral pleura as the anatomic pledget. In our experience when one performs the isolation lobectomy, when the stapling device is fired on the small branches of the pulmonary artery, many times there is a disruption at the branch point because of the torque of the firing of the stapler which is transmitted onto that weak branch point. The use of the anatomic pledget has obviated that problem and that is really where we began doing this.
DR THOMAS M. EGAN (Chapel Hill, NC): Congratulations on a nice series with good results but I have a problem figuring out how you get a 4.5-cm wide tumor through a 2-cm incision.
DR GHARAGOZLOO: If I may describe it, it is very much like childbirth. It is the stretching of the skin incision and so forth and the fact that the pneumobag is lubricated with one bag inside the other. In fact, we are presently in the lab studying a system of two bags that are negatively charged on the surface such that they repel one another, trying to obviate the use of a lubricant, and we are finding that one can perhaps have even a smaller incision, giving a little bit of an advance in technology.
DR EGAN: Ten centimeters is 10 centimeters.
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