Outcomes After Minimally Invasive Reoperation for Gastroesophageal Reflux Disease

Transcription

1 Outcomes After Minimally Invasive Reoperation for Gastroesophageal Reflux Disease James D. Luketich, MD, Hiran C. Fernando, FRCS, FRCSEd, Neil A. Christie, FRCS(C), Percival O. Buenaventura, MD, Sayeed Ikramuddin, MD, and Philip R. Schauer, MD Division of Thoracic and Foregut Surgery and Minimally Invasive Surgery Center, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania Background. Reoperative antireflux surgery is complex and traditionally performed by open methods. Increasingly, surgeons are performing minimally invasive reoperations. This report summarizes our experience with laparoscopic reoperative antireflux surgery (LRAS). Methods. A retrospective review (1996 to 2001) identified 80 LRAS cases. Median age was 49 (22 to 80) years with 52 females and 28 males. Primary symptoms included heartburn (53%), regurgitation (22%), and dysphagia (25%). Detailed outcomes recorded at follow-up included heartburn severity using the Gastroesophageal Reflux Disease-Health Related Quality of Life scale (HRQOL) and SF36 physical (PCS) and mental (MCS) component summary scores. Results. LRAS was completed in 97.5% of cases (two conversions). The most common problems identified were mediastinal migration of the wrap in 48 (60%) and misplaced wrap in 11 (13.8%). LRAS operations included Collis-Nissen (42), Nissen (26), Toupet (six), and six others. Pyloroplasty was required in nine (11%). Complications occurred in 16 patients. These included nine minor gastric perforations (all repaired intraoperatively) and two reoperations for complications (1 patient with a bile leak and the second with a pyloroplasty site leak). Median length of stay was 2.5 days. Median follow-up was 18 (1 to 52) months; 18 (23%) required proton-pump inhibitors. Detailed outcomes were available in 50 patients. Mean PCS and MCS scores were 42 and 47, respectively (normals 50). HRQOL scores were excellent in 35 (65%), satisfactory in 9 (17%), and poor in 10 (18%). Ten patients (18%) reported that they were dissatisfied. Conclusions. LRAS can be performed safely with complication and success rates similar to open operations in a center with extensive laparoscopic experience. (Ann Thorac Surg 2002;74:328 32) 2002 by The Society of Thoracic Surgeons Laparoscopic fundoplication was introduced in 1991 [1]. Over the last decade, improvements in instrumentation and familiarization with techniques have led to the introduction of minimally invasive approaches to other complex esophageal disorders, such as esophageal cancer [2], achalasia [3], and paraesophageal hernia [4]. Reoperation after a failed antireflux operation is a challenging problem, which historically has been performed using open techniques. Morbidity rates between 20% and 40% and mortality rates approaching 2% have been reported with open reoperative fundoplication [5]. The success rate of redo-antireflux operation appears to decline with the number of reoperations required. In a series of 61 patients who had open reoperative antireflux operation, excellent or good results were seen in 85% of patients with one prior operation [6]. This decreased to 66% and 42% in patients who had two and three or more operations, respectively. Minimally invasive approaches to reoperative fundoplication have been recently described [7]. The advantages of a minimally invasive Presented at the Forty-eighth Annual Meeting of the Southern Thoracic Surgical Association, San Antonio, TX, Nov 8 10, Address reprint requests to Dr Luketich, Division of Thoracic and Foregut Surgery, UPMC Presbyterian, 200 Lothrop St, Suite C-800, Pittsburgh, PA 15213; luketichjd@msx.upmc.edu. approach are the potential for shorter recovery and quicker return to home. A recent study compared 65 laparoscopic operations with 35 open operations [8]. Morbidity was 9% for the open compared with 4% for the laparoscopic procedures. Additionally, length of stay was shorter in the laparoscopic group at 2.6 days compared with 7.5 days. This report summarizes our growing experience with laparoscopic reoperative antireflux surgery (LRAS) and represents one of the largest reported series of reoperations. The LRAS patients discussed in this paper are part of an ongoing internal review board approved study on the outcomes of therapy for reflux disease. Material and Methods Review was performed of 80 patients who underwent LRAS at the University of Pittsburgh from January 1996 to May During the same 64-month period, 1,038 primary laparoscopic antireflux procedures were performed at our institution. Additionally, 11 open reoperations were also performed. The 80 LRAS patients included 52 females and 28 males. Median age was 49 (range 22 to 80) years. The primary symptoms leading patients to seek treatment were recurrent heartburn in 42 (53%), dysphagia in 21 (26%), and regurgitation in by The Society of Thoracic Surgeons /02/$22.00 Published by Elsevier Science Inc PII S (02)03713-X

2 Ann Thorac Surg LUKETICH ET AL 2002:74: MINIMALLY INVASIVE REOPERATION FOR GERD 329 (21%). Dysphagia was measured before and after surgery using a scale from 1 (no dysphagia) to 5 (severe dysphagia). The mean preoperative dysphagia score was 2.1, but was higher (3.3) in those patients whose primary complaint was dysphagia. Esophageal dilation was reported by 16 (20%) patients before referral for their redooperation. At the time of reoperation, 49 (61.3%) of the patients were talking proton pump inhibitors (PPI). The reasons for symptom recurrence were obtained by review of endoscopic, upper GI, and operative findings. The most common cause of failure was mediastinal migration of the wrap in 48 (60%) cases, followed by a misplaced wrap constructed over stomach rather than esophagus in 11 (13.8%) patients. Other etiologies included a tight wrap in seven (8.8%), an inadequate (usually partial wrap) in five (6.3%), a disrupted wrap in three (3.8%), and six cases (7.5%) where the etiology was unclear. The median time since the previous antireflux procedure was 24 (range 0.25 to 252) months. Two patients were operated within 1 week of their initial operation. In both cases, the crural repair had disrupted and in both cases successful revision of the crural repair was performed. Seventy-four (92.5%) of the patients had only one prior antireflux operation, 4(5%) had two prior antireflux operations, and 2 (2.5%) patients had three prior operations. In total, 88 prior antireflux procedures had been performed in these 80 patients before their reoperation by our group. The operative approaches used in the 88 operations performed before reoperation by our group included laparoscopy in 56 (64%), laparotomy in 23 (26%), thoracotomy in 7 (8%), and VATS in 2 (2%). Preoperative workup included barium swallow and endoscopy in all patients. Manometry was performed in 68 (85%) and 24-hour ph in 61(76%), with a mean DeMeester score of 52. These tests were not performed if an obvious anatomic defect was noted on upper GI or endoscopy, which clearly explained the patients symptoms. Nuclear medicine gastric emptying studies were performed selectively in 33 (41%) patients. The operative approach used depended on the cause for fundoplication failure. The most common operation was a Nissen fundoplication with a Collis gastroplasty (n 42). Other procedures included Nissen fundoplication (n 26), Toupet fundoplication (n 6), VATS Belsey (n 1), laparoscopic Roux-en-Y gastric bypass (n 2), crural repair (n 2), and 1 patient who required a myotomy with Toupet fundoplication. Currently, our most common approach to LRAS consists of a Nissen fundoplication with a Collis gastroplasty if there is felt to be esophageal shortening. Our usual operative approach is described below. A single-lumen endotracheal tube is used. On table, esophagogastroduodenoscopy is performed in all patients. This allows assessment of Barretts or a stricture if present, the location and integrity of the previous wrap, and evaluation of esophageal length. The patient is supine with the surgeon on the patient s right side. A key technical point is that the first laparoscopic port inserted should be placed away from any previous incisions. Sometimes, placement is required in one of the lower quadrants. Regardless of location, a blunt port cut-down technique is used. Once the peritoneal cavity is visualized, adhesiolysis is performed to allow our usual port placement used to perform laparoscopic antireflux surgery. Typically, five laparoscopic ports are used (two 10 mm and three 5 mm). An advantage of laparoscopy is that a magnified view of the operative field is provided, and the constant flow of carbon dioxide used to insufflate the peritoneal cavity helps opens tissue planes and stretches adhesions. The majority of the dissection is performed using the ultrasonic coagulating shears (US Surgical, Norwalk, CT) Often, the most severe adhesions are located between the stomach, distal esophagus, and liver. Care is taken during this part of the dissection to avoid perforation of the stomach and esophagus. A significant effort is made to identify and protect the vagus nerves. If a patient gives a history suggestive of delayed gastric emptying and has an abnormal nuclear gastric emptying study, a pyloroplasty may be included in the procedure. If hypotension or high airway pressure is detected during the operation, particularly during dissection into the mediastinum, a pneumothorax may be present and should be treated by placement of a chest-tube or pigtail catheter. Although not performed in all of our initial cases, our experience has shown that the previous repair should be taken down completely to fully evaluate the cause of failure. This may require further division of short gastric vessels, and mobilization of the esophageal fat pad to identify the true gastroesophageal junction if not performed previously. If a shortened esophagus is present, a Collis-gastroplasty is added [9, 10]. The requirement for a Collis-gastroplasty may be suspected by radiologic and endoscopic findings. However, the final decision is made in the operating room, after takedown of the previous repair and mobilization of the esophagus into the mediastinum. If less than 3 cm of tension-free intraabdominal esophagus is present, a Collis-gastroplasty is included. A floppy 2- to 3-cm 360-degree Nissen wrap is performed over the esophagus (or neo-esophagus if a Collis gastroplasty is included). The crura are approximated posterior to the wrap. If the crura can not be reapproximated in a tension-free manner, mesh is used to close the crural defect. Our current mesh of choice is Surgisis ES (Cook Surgical, Bloomington, IN). A nasogastric tube is placed under direct vision and usually left overnight and a barium swallow performed the next day. Detailed outcome follow-up included the measurement of quality of life (QOL) using the Short-Form 36 (SF36). The SF36 was not administered preoperatively. The SF36 is a global QOL instrument, which has been extensively validated and United States normal values defined [11]. Scores were expressed as physical component summary (PCS) or mental component summary (MCS) scores. Heartburn severity was also recorded postoperatively using the Gastroesophageal reflux Disease-Health Related Quality of Life scale (HRQOL). This is a disease-specific instrument designed by Velanovich and associates [12], which consists of 10 questions. Nine questions relate to aspects of GERD with each response

3 330 LUKETICH ET AL Ann Thorac Surg MINIMALLY INVASIVE REOPERATION FOR GERD 2002:74: scored from 0 (no symptoms) to 5 (severe symptoms). The best possible score is 0 and worst possible score is 45. HRQOL scores were classified as excellent (0 9), satisfactory (10 15), and poor (15 45). The HRQOL contains a 10th question, which relates to an overall assessment of satisfaction. Raw outcome data were entered and scored using an outcome analyzer software package (Assist Technology, Scottsdale, AZ) and statistical analyses performed on SPSS software (version 10 for Windows). Invasive testing such as manometry and 24-hour ph were not routinely performed after LRAS, unless clinically indicated. Results LRAS was attempted in 80 patients. There were two nonemergent conversions due to dense adhesions preventing successful progress laparoscopically. Pyloroplasty was performed in 9 (11%) patients. Complications occurred in 16 patients. These included minor gastric perforations (n 9), all of which were repaired intraoperatively using simple sutures placed and tied intracorporeally with an endo-stitch (US Surgical). All repairs were successful with no postoperative leaks. Other complications included pneumothorax (1), pulmonary embolus (1), atrial fibrillation (2), ileus (1), and clostridium difficile colitis (1). Two patients required early reoperation for complications. This included 1 patient who developed a leak from his pyloroplasty site and a second who developed a bile leak from the liver parenchyma after extensive adhesiolysis. Both required open repair. There were no operative deaths. The median length of stay was 2.5 (1 25) days. Follow-up was available in 77 patients at a mean of 18 (1 52) months. Proton pump inhibitor use was reported by 18 (23%) patients. All patients underwent an upper GI as in-patient, usually on the first postoperative day. Additionally, 53 patients underwent an upper GI at a mean of 7.8 months after operation with normal results reported in 48 (90.6%). Recurrent reflux symptoms requiring reoperation was required in 7 (8.8%) of the original 80 patients at a mean of 15.1 (6 35) months. The details of these reoperations are outlined in Table 1. As can be seen, 2 of 7 of these patients required more than one revision by our group, but ultimately all had a successful outcome. Excluding the 7 patients requiring reoperation after LRAS and who are described above, detailed outcome follow-up (using the SF36 and HRQOL) was available in 54 patients at a mean of 18 months after LRAS. Dysphagia scores using the scale described in the Methods section improved from 2.0 to 1.3 (p 0.009). Median and mean standard error scores for the outcome instruments were as follows, respectively. The SF36 PCS (normal value 50) scores were 46 and The SF36 MCS scores (normal value 50) were 52 and HRQOL scores were 6 and Based on the HRQOL scores, excellent results were reported in 35 (65%), satisfactory results in 9 (17%), and poor results in Table 1. Details of Reoperations After Failed LRAS Patient Age/ Gender 10 (18%). Ten patients (18%) reported that they were dissatisfied at follow-up. Comment Number of Reoperations Description Approach Current HRQOL (Range 0 45) 30M 1 Collis-Nissen MIS 0 58F 2 Collis-Nissen MIS 0 Roux-en-y MIS 67F 1 Nissen MIS 5 24F 1 Collis-Nissen MIS 10 57M 1 Collis-Nissen MIS 0 59F 1 Collis-Nissen MIS 0 42F 2 Collis-Nissen MIS 0 Roux-en Y CON MIS minimally invasive surgical approach; open operation. CON conversion to In properly selected patients, open fundoplication has been associated with success rates of 91% at follow-up approaching 10 years [13]. The long-term results of laparoscopic surgery are not yet available. Recently, a series of 1,000 laparoscopic cases was reported with 94% of patients reporting that they were satisfied at a median follow-up of 27 months [14]. Although many centers are now routinely performing primary antireflux operations using a minimally invasive approach, this is not the case with reoperative antireflux operation. The operations are both complex and challenging. Even using an open approach, the success rate of reoperative fundoplication rates drop to around 66 to 76% [15]. The Mayo clinic reported one of the largest series of open reoperations for failed antireflux surgery [16]. This series included 185 operations over a 15-year period. Complications occurred in 25.4% of these patients and length of stay was 9 days. Excellent results were reported in 41.6%, good in 18.6%, fair in 43%, and poor results in 12.2%. A key factor to success with reoperative fundoplication is good patient selection. Careful review of the patient s symptoms and preoperative testing before the initial fundoplication will help to determine whether the original fundoplication was indicated. Review of the previous operation note and discussion with the attending surgeon if possible is invaluable. This may help discern the adequacy of mobilization of the distal esophagus, short gastric vessels, and mobilization of the esophageal fat pad. Failure to mobilize the fat pad can lead to difficulty in identifying the gastroesophageal junction and the creation of a misplaced wrap over stomach rather than esophagus. Barium esophagram is key to the identification of anatomical abnormalities. If there is concern of previous vagal injury of delay in gastric emptying, a nuclear gastric emptying study will be of great help. Endoscopy will help to identify the presence of esophagitis, stricture, gastritis,

4 Ann Thorac Surg LUKETICH ET AL 2002:74: MINIMALLY INVASIVE REOPERATION FOR GERD 331 ulceration, and help to evaluate the position and integrity of the wrap. The presence of gastric mucosa above the wrap suggests a slipped Nissen, or the presence of a widely patent gastroesophageal junction suggests a loose or disrupted wrap. Manometry and 24-hour ph studies will help to rule out the presence of motility disorders and confirm the presence of ongoing reflux. The presence of esophageal shortening, and the requirement for an esophageal lengthening procedure, is a controversial issue. Maziak and associates reported that in 91 out of 94 patients with giant hiatal hernia, the esophagus was shortened [17]. A Collis gastroplasty was included in 80% of these cases, with a 93% success rate at a follow-up of 6 years. In contrast, Ellis reported on 55 patients, with only 2 patients having a shortened esophagus [18]. In the Mayo series of open reoperations described above, a Collis gastroplasty was performed in 62.7% of patients [16]. Our operative approach has evolved to include a Collis gastroplasty in most LRAS procedures, as seen in 52.5% of this series. There were no complications in this series by inclusion of a laparoscopic Collis gastroplasty. This series of 80 LRAS operations is one of the largest reported. LRAS can be performed safely with complication rates similar to open operation. As reported with open operation, success rates decline in patients undergoing redo-antireflux surgery. However, overall heartburn control was good, with 18% of patients stating that they were dissatisfied at a median follow-up of 16 months. LRAS is an acceptable approach in centers experienced in minimally invasive surgery of the esophagus. References 1. Dallemagne B, Weerts JM, Jehaes C, et al. Laparoscopic Nissen fundoplication: preliminary report. Surg Endosc 1991;3: Luketich JD, Schauer PR, Christie NA, et al. Minimally invasive esophagectomy Ann Thorac Surg 2000;70: Luketich JD, Fernando HC, Christie NA, et al. Outcomes after minimally invasive esophagomyotomy. Ann Thorac Surg 2001;72: Luketich JD, Raja S, Fernando HC, et al. Laparoscopic repair of giant paraesophageal hernia: 100 consecutive cases. Ann Surg ;4: Siewert JR, Stein HJ, Feussner H. Reoperations after failed antireflux procedures. Ann Chir Gynaecol 1995;84: Little AG, Ferguson MK, Skinner DB. Reoperation for failed antireflux operations. J Thorac Cardiovasc Surg 1986;91: Horgan S, Pohl D, Bogetti D, Eubanks T, Pellegrini C. Failed antireflux surgery. What have we learned from reoperations? Arch Surg 1999;134: Hunter JG, Smith CD, Branum GD, et al. Laparoscopic fundoplication failures. Patterns of failure and response to fundoplication revision. Ann Surg 1999;230: Luketich JD, Grondin SG, Pearson FG. Minimally invasive approaches to acquired shortening of the esophagus: laparoscopic Collis-Nissen gastroplasty. Sem Thorac Cardiovasc Surg 2000;12; Johnson AB, Oddsdottir M, Hunter JG. Laparoscopic Collis gastroplasty and Nissen fundoplication: a new technique for the management of esophageal foreshortening. Surg Endosc 1998;12: Ware JE, Scherbourne CD. The MOS 36-item short form health survey (SF36). Med Care 1992;30: Velanovich V, Vallance SR, Gusz JR Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg 1996;183: DeMeester TR, Bonavina L, Albertucci M. Nissen fundoplication for gastroesophageal reflux disease. Ann Surg 1986; 204: Terry M, Smith CD, Branum K, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia: experience with 1000 consecutive cases. Surg Endosc 2001; 15: Siewert JR, Isolauri J, Feussner H. Reoperation following failed fundoplication. World J Surg 1989;13: Deschamps C, Trastek VF, Allen MS, Pairolero PC, Johnson JO, Larson DR. Long-term results after re-operation for failed antireflux procedures. J Thorac Cardiovasc Surg 1997; 113: Maziak DE, Todd TR, Person FG. Massive hiatus hernia: evaluation and surgical management. J Thorac Cardiovasc Surg 1998;115: Ellis FH, Crozier RE, Shea JA. Paraesophageal hiatus hernia. Arch Surg 1986;121: DISCUSSION DR DARRYL S. WEIMAN (Memphis, TN): One of your initial slides implied that with laparoscopic techniques the incidence of the disease has gone up. I was not aware that the laparoscope caused reflux esophagitis. DR FERNANDO: I think that is just that as minimally invasive techniques are becoming more available, we are seeing earlier referral of the patients to the surgeon. We are seeing a rising incidence of esophageal adenocarcinoma in the West. Perhaps there is a rising incidence of reflux as well. Certainly, as the laparoscopic approach has become more common, the number of antireflux operations has increased. DR WEIMAN: It seems to me that a lot more are being done because people are now able to do them through the laparoscope. How do you even know they had the disease? You did not do ph monitoring. DR FERNANDO: Actually, with regards to our redo patients, all are aggressively worked up. I did not detail our preoperative evaluation in the presentation. All patients have a barium swallow to look for anatomical defects, all patients have an endoscopy, all patients will have had either 24-hour ph before their first operation or before their reoperation, and all patients will have manometry. We also will assess how these patients respond to proton pump inhibitors and look for some improvement in symptoms with proton pump inhibitors. If there is no response to proton pump inhibitors, this raises doubt about the validity of the diagnosis of recurrent reflux. I should also mention that because of difficulty in sometimes identifying the vagus nerves at reoperation, and if patients complain of bloating before their operation, we will often include a nuclear gastric emptying study as well. DR WEIMAN: How do you do a Belsey through the belly?

5 332 LUKETICH ET AL Ann Thorac Surg MINIMALLY INVASIVE REOPERATION FOR GERD 2002:74: DR FERNANDO: That 1 patient had the procedure performed through the chest. This was a VATS approach, not a laparoscopic approach. DR THOMAS A. D AMICO (Durham, NC): Dr Fernando, that is a remarkable series, considering both the technical aspects of the surgery as well as the completeness of the quality of life follow-up. I just have a couple of questions. The first, in what percentage of the 80 patients were you able to obtain the previous operative notes and did you consider that critical prior to proceeding laparoscopically? Second, you mentioned that you had nine gastric perforations but you had no esophageal perforations. That seems odd to me. It would seem that there would be at least some esophageal perforations. And lastly, you did not list the length of the operation or the length of stay, and you did not really make the case, although it probably is not the focus of your paper, that there is any advantage of doing this laparoscopically compared with open. I think you need to make that case. I enjoyed your paper very much. DR FERNANDO: Regarding the old operation notes, I think this is a very important point. We always try and get hold of the old operation notes to review what was done in the previous operation. I do not know the numbers as to how many cases we did have access to the prior operation. There were no esophageal perforations in this study. Certainly, in some of our operations performed for giant hiatal hernias, we have seen esophageal perforations. The reason I believe we saw gastric perforations rather than esophageal perforations is that often the adhesions between the left lobe of the liver and the stomach, and previous wrap can be particularly dense. Sometimes as these are taken down, these small perforations occur. But, as I mentioned, in all of these cases, we were able to recognize these perforations and repair them endoscopically without further sequelae in any patient. In terms of a comparison with open operations, really there is only historical data to go by. We did not perform a randomized study and we did not compare our open reoperative data to our laparoscopic approaches because we simply did not have many open reoperations to compare with. One of the earlier slides I presented summarizing data from the Mayo clinic on open reoperation showed a 25% complication rate and a length of stay of 9 days. Granted, that this was taken over a 35-year period, whereas our study was performed over a more recent 5-year period, when there is a trend to send patients home sooner and out of the hospital quicker than it would have been 35 years ago. Internet Discussion Forum Each month, we select an article from The Annals of Thoracic Surgery for discussion within the Surgeon s Forum of the CTSNet Discussion Forum Section. The articles chosen rotate among the six dilemma topics covered under the Surgeon s Forum, which include: General Thoracic Surgery, Adult Cardiac Surgery, Pediatric Cardiac Surgery, Cardiac Transplantation, Lung Transplantation, and Aortic and Vascular Surgery. Once the article selected for discussion is published in the online version of The Annals, we will post a notice on the CTSNet home page ( with a FREE LINK to the full-text article. Readers wishing to comment can post their own commentary in the discussion forum for that article, which will be informally moderated by The Annals Internet Editor. We encourage all surgeons to participate in this interesting exchange and to avail themselves of the other valuable features of the CTSNet Discussion Forum and web site. For August, the article chosen for discussion under the Pediatric Cardiac Surgery Dilemma Section of the Discussion Forum is: Early Failure of the Shelhigh Pulmonary Valve Conduit in Infants Jeffrey M. Pearl, MD, David S. Cooper, MD, Kevin E. Bove, MD, and Peter B. Manning, MD Tom R. Karl The Annals Internet Editor UCSF Children s Hospital Pediatric Cardiac Surgical Unit 505 Parnassus Ave, Room S-549 San Francisco, CA Phone: (415) Fax: (212) karlt@surgery.ucsf.edu by The Society of Thoracic Surgeons Ann Thorac Surg 2002;74: /02/$22.00 Published by Elsevier Science Inc