JAMA Surgery

Granderath, Frank A.; Kamolz, Thomas; Schweiger, Ursula M.; Pointner, Rudolph

doi: 10.1001/archsurg.141.7.625pmid: 16847231

HypothesisProsthetic crural closure does not adversely influence esophageal body motility. In most patients, postoperative increased dysphagia resolves spontaneously during the first months after surgery.DesignProspective randomized trial. We compared patients who underwent laparoscopic Nissen fundoplication with simple sutured hiatal closure and those who underwent laparoscopic Nissen fundoplication with prosthetic hiatal closure.SettingUniversity-affiliated community hospital.PatientsForty consecutive patients who underwent laparoscopic Nissen fundoplication for gastroesophageal reflux disease.InterventionsA 360° Nissen fundoplication with simple sutured crura (n = 20; nonmesh group) vs the same procedure with posterior 1 × 3-cm polypropylene onlay mesh prosthesis (n = 20; mesh group).Main Outcome MeasuresRecurrences; postoperative dysphagia rate; localization, length, and pressure of the lower esophageal sphincter (LES); results of 24-hour pH monitoring; esophageal body motility; peristalsis; and esophageal amplitude of contraction and interrupted waves.ResultsPreoperatively, both groups had pathological LES pressure and DeMeester scores. These values improved significantly (P<.01) after surgery and remained stable at 1 year after surgery. Patients in the nonmesh group had a significantly lower LES pressure 1 year after surgery compared with those in the mesh group. There were no significant differences in postoperative mean LES length (4.1 vs 3.8 cm), LES relaxation (93.4% vs 92.4%), and intra-abdominal LES length (2.1 vs 2.1 cm). Patients in the mesh group had fewer simultaneous waves and interrupted waves 1 year after surgery, but the difference between groups was not significant. There were no significant differences in interrupted waves and amplitude of contraction between groups 1 year after surgery.ConclusionLaparoscopic Nissen fundoplication with prosthetic crural closure does not impair postoperative esophageal body motility compared with laparoscopic Nissen fundoplication with simple suture hiatal closure, although it is associated with a higher rate of short-term dysphagia.The primary goal of laparoscopic antireflux surgery (LARS) is to create an antireflux barrier by performing a fundoplication and hiatal closure. Gastroesophageal reflux disease (GERD) is frequently accompanied by the presence of hiatal hernia; therefore, most authors agree that routine crural closure has to be added to fundoplication in LARS or in large-hernia repair.The most common morphological complication after LARS for GERD or hiatal hernia is the postoperative migration of the intact fundic wrap into the mediastinum.This complication usually leads to recurrent or persistent GERD symptoms such as dysphagia, recurrent reflux, or a combination of both. To prevent postoperative intrathoracic wrap herniation, some authors have advocated the use of prosthetic materials for closure of the hiatal crura.Especially in LARS for large hiatal hernia repair but also for GERD, prosthetic hiatal closure can reduce the postoperative recurrence rate significantly.However, the use of prosthetic mesh for crural closure appears to cause some adverse effects. In a large nonrandomized study,we evaluated the outcome of LARS with mesh hiatoplasty by comparing patients who underwent LARS with simple sutured crural closure with patients who underwent LARS with a prosthetic hiatoplasty. Patients with mesh hiatoplasty had a significantly higher rate of postoperative dysphagia 3 months after surgery, which decreased spontaneously at the 1-year follow-up.The aim of the present study was to recontrol these findings thoroughly by performing a prospective randomized trial to clarify the following questions: (1) Does the use of prosthetic mesh for crural closure influence esophageal body motility? (2) Is prosthetic hiatal closure associated with a higher dysphagia rate? (3) If so, for what postoperative period does the higher dysphagia rate remain?METHODSForty patients with GERD (12 women and 28 men; mean age, 47.6 years [range, 24-68 years]) were allocated for laparoscopic 360° “floppy” Nissen fundoplication at our surgical unit. All patients had a long history of GERD symptoms (mean, 4.2 ± 3.1 years) and had been treated with proton pump inhibitors for a minimum of 6 months (20-60 mg/d). The mean height of patients was 172.5 cm (range, 163-191 cm), with a mean weight of 78.2 kg (range, 52-101 kg). Six patients (15%) had a histologically verified Barrett esophagus. Twenty-one patients (52%) had a hiatal hernia smaller than 5 cm; 19 patients (48%) had a hiatal hernia larger than 5 cm. The complete demographic data of all patients subdivided into the 2 surgical groups are shown in the Table.Table. Preoperative Demographics of PatientsPatient GroupMeshNonmeshDemographic characteristics Sex, No. W/M5/57/13 Age, mean, y46.948.3 Weight, mean, kg81.774.7 Height, mean, cm179.2165.8Pathological features, No. of patients Barrett esophagus33 Hiatal hernia, cm  <51110  >5910 No. of hiatal sutures, mean2.82.0 Preoperative LES pressure, mean, mm Hg3.63.1 Preoperative DeMeester score, mean53.466.1 Abbreviation: LES, lower esophageal sphincter.All patients were stratified prospectively and randomized to laparoscopic 360° Nissen fundoplication with prosthetic hiatal closure (n = 20; mesh group) or laparoscopic 360° Nissen fundoplication with simple sutured hiatal closure (n = 20; nonmesh group).Randomization to simple sutured hiatal closure or prosthetic hiatal closure was performed via random sampling numbers immediately before surgery by an independent physician to ensure blind assessment of outcome.ESOPHAGOGASTRODUODENOSCOPYAll patients underwent routine standardized esophagogastroduodenoscopy (EGD) with biopsy of the gastroesophageal junction and consecutive histological examination for detection of Barrett esophagus. In addition, the presence and extent of hiatal hernia was determined.ESOPHAGEAL MANOMETRYStationary pull-through esophageal manometry was performed using a water-perfused polyvinyl catheter (Medtronic Inc, Minneapolis, Minn) with side holes connected to an external transducer assembly. The catheter combines 5 capillary tubes 0.8 mm in diameter with side openings at 5 different levels. The holes are radially spaced 5 cm apart for esophageal body motility study. After an overnight fast, the catheter is introduced transnasally until all 5 holes are in an intra-abdominal position, which is noted by a pressure increase on inspiration. For identification of the high-pressure zone of the lower esophageal sphincter (LES), the catheter is withdrawn across the cardia. The catheter is withdrawn 1 cm at a time. The following values are noted: (1) distal border of the LES, (2) respiratory inversion point, and (3) upper border of the LES.From these measurements, LES overall length, intra-abdominal length, and pressure are determined. For assessment of esophageal body motor function, the most distal pressure transducer is located 1 cm above the upper border of the LES. With this method, the pressure response throughout the whole esophagus can be obtained by swallowing. The response to 10 wet swallows (each 5 mL of water) is then recorded. Amplitude, duration, number of peaks, and esophageal activity of contractions after each swallow are measured at each level of the esophageal body. The esophageal contraction waves after a swallow are classified as peristaltic, simultaneous, or interrupted. Esophageal dysmotility was defined as an amplitude of less than 30 mm Hg in the lower segments in response to wet swallows and peristalsis of greater than 40% of simultaneous contractions in wet swallows.24-HOUR pH MONITORINGStationary 24-hour pH monitoring was performed using an antimony pH sensor (Synetics, Stockholm, Sweden). All patients stopped using proton pump inhibitors or histamine2-blocker medication at least 7 days before monitoring. After location during primary esophageal manometry, the pH electrode is placed 5 cm above the upper border of the LES. Before and after 24-hour pH monitoring, the sensor was calibrated in buffer solution (pH, 7 and 1; Synetics). The data were analyzed by downloading in a personal computer using commercially available software (Polygram; Synetics). Pathological acid reflux was defined as a DeMeester score higher than 14.72.SYMPTOMATIC EVALUATIONPreoperatively, the subjective value of postoperative dysphagia was measured using a simple verbal rating scale subdivided into none, mild, moderate, and severe. In addition, after surgery, all patients were classified using the following dysphagia score: able to eat solid food (1), able to eat semisolid food (2), able to swallow liquids only (3), and dysphagia for solids, semisolids and liquids (complete obstruction; 4).SURGICAL TECHNIQUEAll patients of both groups underwent laparoscopic 360° floppy Nissen fundoplication in a standardized manner by 2 laparoscopic experienced surgeons (F.A.G. and R.P.) as described recently.In the nonmesh group, the hiatal crura were closed using 1 to 4 simple nonabsorbable interrupted sutures, depending on the size of hiatal defect (Figure 1). In the mesh group, the hiatal crura were primarily closed with simple sutures and additionally reinforced with a 1 × 3-cm polypropylene mesh (Figure 2).Figure 1.Simple sutured hiatoplasty.Figure 2.Polypropylene mesh (1 × 3 cm) as used in hiatoplasty.FOLLOW-UPAt the day of discharge, the extent of dysphagia was evaluated using the scoring system as described in the “Symptomatic Evaluation” subsection. Standardized follow-up occurred 6 weeks, 3 months, and 1 year after surgery.All 40 patients were available for complete follow-up. Routine EGD at our surgical unit or by a local gastroenterologist was performed 6 weeks after surgery. At 3 months and 1 year after surgery, esophageal manometry, 24-hour pH monitoring, cinematographic radiography (barium swallow), and evaluation of dysphagia were performed. In all patients who were referred to our unit in the meantime with any kind of persistent or recurrent signs of GERD symptoms during follow-up, routine EGD and cinematographic radiography were performed.STATISTICSWe used commercially available software (SPSS program; SPSS Inc, Chicago, Ill) for statistical analysis comparing baseline differences between the surgical groups and treatment results using tests as appropriate. A Pvalue <.05 was considered statistically significant. Data are reported as mean, mean ± SD, range, or percentage.RESULTSAll procedures could be completed laparoscopically with no intraoperative complications in either surgical group. There was no significant difference in mean operating time between groups (mesh group, 59 minutes; nonmesh group, 55 minutes). There were no significant differences between groups regarding demographic data such as age, sex, weight, or height (Table). Preoperative and postoperative evaluation of symptomatic outcome, upper gastrointestinal tract endoscopy, esophageal manometry, and 24-hour pH monitoring were performed in all patients.ESOPHAGOGASTRODUODENOSCOPYPreoperatively, 3 patients (15%) in each group had a histologically verified Barrett esophagus. All patients in both groups presented with a hiatal hernia at preoperative EGD. A small hiatal hernia (<5 cm) could be detected in 11 patients in the mesh group (55%) and in 10 patients in the nonmesh group (50%). In 9 patients in the mesh group (45%) and 10 patients in the nonmesh group (50%), hiatal hernia was larger than 5 cm.At the 6-week follow-up examination, no patient in either surgical group showed any signs of recurrent hiatal hernia and/or intrathoracic wrap migration.CINEMATOGRAPHIC RADIOGRAPHYDuring the complete follow-up, no patient in either group showed pathological findings on cinematographic radiography, especially signs of postoperative intrathoracic wrap migration.ESOPHAGEAL MANOMETRY: LESMean LES LengthFigure 3shows the mean LES length in both groups. Preoperatively, the mean LES length is similar in both groups (mesh group, 2.0 cm; nonmesh group, 2.0 cm). The LES length increased significantly (P<.01) at 3 months (mesh group, 3.6 cm; nonmesh group, 3.8 cm) and 1 year (mesh group, 4.1 cm; nonmesh group, 3.8 cm) after surgery and was comparable in both groups.Figure 3.Comparison of lower esophageal sphincter (LES) length between groups undergoing mesh and nonmesh hiatoplasty.Mean Intra-abdominal LES LengthThe proportion of the LES within the abdomen showed no significant differences between the surgical groups. Despite a significant increase (P<.05) from preoperative values (mesh group, 1.1 cm; nonmesh group, 0.9 cm) to postoperative values at 3 months (mesh group, 2.2 cm; nonmesh group, 2.5 cm) and 1 year (mesh group, 2.1 cm; nonmesh group, 2.1 cm), a significant difference between groups was not detected (Figure 4).Figure 4.Comparison of intra-abdominal lower esophageal sphincter (LES) length between groups undergoing mesh and nonmesh hiatoplasty.LES PressurePreoperatively, the mean LES pressure was pathological and similar in both groups (mesh group, 3.6 ± 1.8 mm Hg; nonmesh group, 3.1 ± 1.7 mm Hg). At the 3-month follow-up, the LES pressure improved significantly (P<.01) to 12.9 ± 4.8 mm Hg in the mesh group and 12.0 ± 4.0 mm Hg in the nonmesh group. At the 1-year follow-up, a significant difference between groups was found (Figure 5). In mesh group patients, the LES pressure remained stable at 13.9 ± 4.9 mm Hg; in nonmesh group patients, the LES pressure decreased to 8.9 ± 3.7 mm Hg (P<.01).Figure 5.Comparison of lower esophageal sphincter (LES) pressure between groups undergoing mesh and nonmesh hiatoplasty.Mean LES RelaxationThe mean LES relaxation was almost complete in both groups (mesh group, 99.7%; nonmesh group, 99.3%). After surgery, the mean LES relaxation decreased to 87.4% in the mesh group and to 92.2% in the nonmesh group (both, P<.05). At 1 year after surgery, LES relaxation increased again and was comparable in both groups (mesh group, 93.4%; nonmesh group, 92.4%) (Figure 6).Figure 6.Comparison of lower esophageal sphincter (LES) relaxation between groups undergoing mesh and nonmesh hiatoplasty.ESOPHAGEAL MANOMETRY: ESOPHAGEAL BODY MOTILITYAmplitude of Contractions in Wet SwallowsMesh GroupIn the mesh group, the postoperative mean amplitude of contractions in wet swallows showed a significant improvement in all 5 esophageal levels compared with preoperative values (P<.05). At the 1-year follow-up, this improvement remained constant in all esophageal segments but level 5. In level 5, the amplitude at first increased from a preoperative level of 52.3 mm Hg to 63.6 mm Hg at 3 months, but again decreased to 61.9 mm Hg at the 1-year follow-up (Figure 7).Figure 7.Amplitude of contractions in wet swallows in the group undergoing mesh hiatoplasty.Nonmesh GroupPreoperatively, the mean amplitude of contractions in wet swallows was pathological in levels 3 to 5 and improved significantly during follow-up to normal values at the 1-year follow-up (P<.05). In level 4, after primary improvement from a preoperative value of 32.2 mm Hg to 46.8 mm Hg at 3 months, the amplitude decreased minimally to 45.3 mm Hg at 1 year. In level 5, the amplitude increased significantly from a preoperative value of 23.7 mm Hg to 47.9 mm Hg at 3 months, but then decreased to 38.1 mm Hg at 1 year (P<.05) (Figure 8).Figure 8.Amplitude of contractions in wet swallows in the group undergoing nonmesh hiatoplasty.Esophageal Peristalsis: Simultaneous WavesMesh GroupIn general, no pathological simultaneous waves were found in the mesh group. Simultaneous waves were detected only in levels 2 and 5. In level 2, the mean percentage of simultaneous waves was 10% and decreased completely at both postoperative examinations. In level 5, the preoperative value of 10% recurred at the 1-year follow-up (Figure 9).Figure 9.Esophageal peristalsis measured in simultaneous waves in the group undergoing mesh hiatoplasty.Nonmesh GroupIn levels 1 and 2, no pathological values could be detected. In level 3, 30% simultaneous waves were found 1 year after surgery. In level 4, preoperative values of 30% remained stable at 3 months after surgery and decreased to 20% at 1 year. In level 5, preoperative 20% simultaneous waves decreased completely at 3 months and 1 year postoperatively (Figure 10).Figure 10.Esophageal peristalsis measured in simultaneous waves in the group undergoing nonmesh hiatoplasty.Esophageal Peristalsis: Interrupted WavesMesh GroupGenerally, the preoperative percentage of interrupted waves was nonpathological in all esophageal levels. In level 2, the preoperative value of 50% increased to 80% at 3 months after surgery, but then decreased completetely at 1 year. Levels 1 and 5 showed no interrupted waves in all examinations. In level 2, 80% interrupted waves were detected at 3 months; in level 3, 10% interrupted waves were found at 3 months (Figure 11).Figure 11.Esophageal peristalsis measured in interrupted waves in the group undergoing mesh hiatoplasty.Nonmesh GroupPostoperative interrupted waves only could be detected in levels 2 and 5. In level 2, the preoperative percentage of 30% decreased to 20% at the 1-year follow-up. In level 5, the preoperative percentage of 30% at first decreased completely at 3 months, but then increased to 50% at 1 year after surgery (P<.05) (Figure 12).Figure 12.Esophageal peristalsis measured in interrupted waves in the group undergoing nonmesh hiatoplasty.24-HOUR pH MONITORINGThe mean DeMeester score in both surgical groups improved significantly from a preoperative 66.1 ± 11.7 to 7.5 ± 3.1 at 3 months and 8.9 ± 2.2 at 1 year after surgery in the mesh group and from a preoperative 53.4 ± 9.9 to 8.8 ± 1.9 at 3 months and 7.0 ± 1.8 at 1 year after surgery in the nonmesh group (P<.01). A significant difference between surgical groups was not found (Figure 13).Figure 13.Comparison of the DeMeester score between groups undergoing mesh and nonmesh hiatoplasty.SYMPTOMATIC OUTCOMEPreoperatively, 1 patient in the mesh group (5%) and 2 patients in the nonmesh group (10%) reported mild to moderate dysphagia. Postoperatively, a significant difference in the subjective extent of dysphagia was found between surgical groups. At the time of discharge (1 week postoperatively), 4 patients in the mesh group (20%) had dysphagia of grades 1 to 2, whereas 1 patient in the nonmesh group (5%) had dysphagia of grade 1 at this time (P<.05). At the 6-week and 3-month follow-ups, this ratio was almost unchanged. At 6 weeks, 4 patients in the mesh group (20%) had dysphagia of grades 1 to 2 in contrast to 2 patients in the nonmesh group (10%) (P<.05). Three months after surgery, the overall dysphagia rate decreased to 15% (n = 3) in the mesh group and to 5% (n = 1) in the nonmesh group (P<.05). At the 1-year follow-up, this significant difference disappeared because the dysphagia rate became equal in both surgical groups at 5% (n = 1 in each group) (Figure 14).Figure 14.Comparison of the dysphagia rate between groups undergoing mesh and nonmesh hiatoplasty.COMMENTLaparoscopic antireflux surgery has proved to be a successful treatment alternative to lifelong medical treatment of GERD.During the past few years, several studieshave shown that LARS is a safe and effective procedure with good long-term symptom relief and a significant improvement of patients' quality of life, especially in patients with anatomical morphological causes for GERD symptoms. However, despite these good results, it has been shown that LARS can also fail in a small percentage of patients and result in persistent or recurrent GERD symptoms.The underlying morphological causes of recurrent GERD symptoms like dysphagia, recurrent reflux, or a combination of both are multifarious.In many cases, postoperative dysphagia is the result of too tight or complete hiatal closure during the laparoscopic antireflux procedure. Inadequate or too loose hiatal closure will lead to postoperative hiatal disruption or hiatal insufficiency with consequent recurrent hiatal hernia and/or intrathoracic migration of the fundic wrap. In particular, the intrathoracic wrap migration has been the most frequent morphological complication after LARS and has been described as the most common complication leading to revision surgery after failed LARS.To prevent or minimize the rate of postoperative intrathoracic wrap migrations, some authorshave advocated the use of prosthetic materials for hiatal reinforcement. The use of prosthetic patches for reinforcement of the hiatal crura has proved to be an efficient method for prevention of postoperative intrathoracic wrap migration, especially in patients with large hiatal hernia or paraesophageal hernia.In a recent trial by Frantzides et al,72 patients were prospectively randomized to laparoscopic Nissen fundoplication with simple sutured hiatal closure (n = 36) or laparoscopic Nissen fundoplication with prosthetic cruroplasty using a polytetrafluoroethylene patch. After a mean follow-up of 3.3 years, the postoperative hiatal hernia recurrence rate was significantly higher in the nonmesh group (22% vs 0%). In a study by Basso et al,65 consecutive patients underwent laparoscopic Nissen fundoplication with simple sutured hiatal closure and had an intrathoracic wrap migration rate of 13.8% for a mean follow-up period of 48.3 months. Therefore, the authors used a 3 × 4-cm polypropylene mesh for hiatal closure in another 67 patients and reduced the postoperative intrathoracic wrap migration rate to 0% for a follow-up period of 22.5 months.Like other investigators,postoperative intrathoracic wrap migration has been the most frequent morphological complication after LARS in our clinical practice. This common complication has also led us to the use of a 1 × 3-cm polypropylene mesh for reinforcement of the hiatal crura. In a nonrandomized study, we compared 361 patients with GERD who underwent laparoscopic fundoplication with simple sutured hiatal closure and a group of 170 patients who underwent laparoscopic fundoplication with prosthetic hiatal closure using a 1 × 3-cm polypropylene mesh. After a complete postoperative follow-up of 1 year, we found a significant difference in the occurrence of postoperative intrathoracic wrap migration, ie, 6.1% in the nonmesh group vs 0.6% in the mesh group. Despite these good results, we also saw a significantly higher rate of postoperative dysphagia in the patients who underwent prosthetic hiatal closure.At the 3-month follow-up examination, 35.3% of patients who had the mesh prosthesis had postoperative dysphagia compared with 19.8% of patients undergoing simple sutured hiatal closure. Nevertheless, at the 1-year follow-up, 95% of patients in both groups were free of dysphagia, and the dysphagia rates were equal in both groups and comparable to preoperative values (4.9% vs 4.4%).To verify these results thoroughly, we performed a prospective randomized trial to determine the morphological reasons for this higher dysphagia rate in our patients. Therefore, we prospectively randomized 40 patients to laparoscopic Nissen fundoplication with simple sutured hiatal closure (n = 20) or laparoscopic Nissen fundoplication with simple sutures in addition to a 1 × 3-cm polypropylene mesh (n = 20). Complete follow-up data of both groups for 1 year after surgery were evaluated, with the main focus on data of esophageal manometry and esophageal body motility.The preoperative rate of dysphagia in both groups showed no significant difference in this trial, but again, a significant difference in the postoperative dysphagia rate could be detected at follow-up examinations; ie, at the 3-month follow-up, patients in the mesh group had a constantly higher rate of dysphagia than those in the nonmesh group. At 1 and 6 weeks after surgery, a postoperative dysphagia rate of 20% was found in the mesh group, which decreased to 15% at the 3-month follow-up. However, as shown in our previous study,no significant difference between groups could be found at the 1-year follow-up. Almost 95% of patients of both groups were free of dysphagia, and the 1-year follow-up dysphagia rate was equal (5% in each group).Obviously, prosthetic hiatal closure is associated with a higher postoperative dysphagia rate for short-term and midterm follow-up, but the rate decreases and becomes comparable to the dysphagia rates of patients who underwent simple sutured hiatal closure for long-term follow-up.Until now, few data were available regarding the influence of prosthetic material for hiatal closure on esophageal body motility and/or the LES as a reason for postoperative dysphagia. Impaired esophageal body motility and/or high LES pressures are morphological causes of dysphagia.In the present study, all patients of both groups had pathological LES pressure but esophageal body motility test results within the reference range. At 3 months postoperatively, a significant increase of the mean LES pressure was found in both groups, with no significant differences between the mesh group and the nonmesh group. One year after surgery, nonmesh group patients had a significantly lower LES pressure compared with mesh group patients. A significant difference in LES length or relaxation between groups could not be detected.Preoperatively, the values of esophageal body motility testing showed values within the reference range in both surgical groups. The limit to pathological values for the amplitude of contractions in wet swallows was fixed at less than 30 mm Hg in the lower esophageal segments. Preoperatively, values completely within the reference range were found in all 5 esophageal segments for patients in the mesh group, and marginal reference values were found in levels 3 and 5 in the nonmesh group. Postoperatively, the amplitude improved significantly in both surgical groups to 1 year after surgery; however, overall values of the nonmesh group were lower at follow-up but did not fall below the limit of pathological values. Preoperative and postoperative esophageal peristalsis showed nonpathological values regarding simultaneous waves in both groups. Patients in the mesh group presented 10% simultaneous waves in level 5 at 1 year postoperatively; patients in the nonmesh group had 30% simultaneous waves at level 3 and 20% at level 4, which correlates with reference values. A significant difference between the groups was not detected.We found comparable results regarding interrupted waves in esophageal peristalsis. Preoperative and postoperative data showed marginal reference values in both groups except for those for level 5 in the nonmesh group: preoperative 30% interrupted waves decreased completely at the 3-month follow-up, but increased significantly to 50% at the 1-year follow-up.In general, these results show that patients with prosthetic hiatal closure have comparable results in esophageal manometry and body motility studies to those of patients who underwent simple sutured hiatal closure. Actually, patients in the nonmesh group have lower values in esophageal body motility, regardless of their lower rate of postoperative dysphagia. As our data show, prosthetic hiatal closure does not significantly impair esophageal body motility and, accordingly, the postoperative higher dysphagia rate is not the result of mesh-related impaired esophageal body motility.The high postoperative dysphagia rate remains at short-term follow-up but seems to be transient. Certainly, postoperative short-term dysphagia is the result of the rapid incorporation of polypropylene mesh and the tendency of this material to develop early postoperative adhesions with subsequent ingrowth of the hiatal crura, which normalizes during longer postoperative periods. Despite these results, further investigations are needed to clarify the morphological causes of this transient dysphagia and to evaluate the postoperative dysphagia rate for longer follow-up.Correspondence:Frank A. Granderath, MD, Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, D-72076 Tübingen, Germany ([email protected]).Accepted for Publication:May 19, 2005.Previous Presentations:This study was presented at the First European Endoscopic Surgery Week and the 11th International Congress of the European Association for Endoscopic Surgery; June 17, 2003; Glasgow, Scotland; and as a poster at the 45th Annual Meeting of the Society for Surgery of the Alimentary Tract, Digestive Disease Week; May 17-18, 2004; New Orleans, La. This study was published as an abstract in Gastroenterology.2004;126(4):309. 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Moretti, Eugene W.; Newman, Mark F.; Muhlbaier, Lawrence H.; Whellan, David; Petersen, Rebecca P.; Rossignol, Daniel; McCants, Charles B.; Phillips-Bute, Barbara; Bennett-Guerrero, Elliott

doi: 10.1001/archsurg.141.7.637pmid: 16847232

Kron, Irving L.

doi: 10.1001/archsurg.141.7.642pmid: N/A

Moretti and colleagues from Duke University have demonstrated that preoperative levels of EndoCAb are associated with increased long-term mortality after CABG surgery using CPB. This is truly a unique finding and worthy of further discussion. Essentially, this finding implies that increased EndoCAb levels carry increased short- and long-term risks after CABG surgery. Although the findings are statistically significant, I’m not sure I understand the logic of this finding. We don't know why the patients died in either subgroup, so it is difficult to explain the increased long-term mortality based on potential increases in EndoCAb levels. In addition, it does not seem that the authors have excluded 30- or 60-day mortality from the analysis. The authors explained in their discussion their thoughts about this association. They stated that low EndoCAb levels may potentially be a marker for increased operative risk. Although they used the Parsonnet additive risk score to stratify risks, this by itself did not explain the difference in mortality. Perhaps a decreased EndoCAb level provides risk stratification different from the Parsonnet additive risk score. We know that the so-called eyeball test may be the best indicator for how a patient will do after surgery. Such patients look alert, bright, and full of energy, and these patients will do well. Perhaps decreased EndoCAb levels may be a surrogate for how patients look and feel. The authors are correct that further analyses are important to determine whether this is a real association. Presently, I am not sure where this finding should fit in our analysis of patient risks. Correspondence: Dr Kron, Department of Surgery, Box 181, University of Virginia Health Sciences Center, Charlottesville, VA 22908 ([email protected]).

McLean, Thomas R.

doi: 10.1001/archsurg.141.7.643pmid: 16847233

HypothesisLimited information exists on the outcome of laparoscopic cholecystectomy (LC) litigation.DesignA retrospective review of a public malpractice database was compared with previously published reviews of LC litigation by K. A. Kern, MD, and the Physician Insurers Association of America.SettingPrivate surgery practice.SelectionThe database was searched for cases containing the terms laparoscopy, bile, or gallbetween August 1, 1999, and August 31, 2004. Identified cases were further reviewed to select only the unique cases that concerned elective biliary surgery.Main Outcome MeasuresSurgical technique, injuries, and incidence of conversion to open procedures.ResultsIn Kern's study, injuries triggering litigation involved the bile duct in 61%, bowel in 16%, vascular system in 9%, and miscellaneous events in 14%; in the present study, injuries involved the bile duct in 78%, bowel in 2%, vascular injury in 7%, and miscellaneous injuries in 13%. Missed injuries occurred in 86% in the present study and 83% of the Physician Insurers Association of America cases. Although 15% of cases in the present study were converted to open procedures, in 53% of these cases conversion was performed to repair an injury.ConclusionsDespite residency training, injuries triggering litigation after LC remain largely unchanged. The nature of the bile duct injuries suggests that routine intraoperative cholangiography is unlikely to make LC safer. To minimize the risk of litigation after LC, it is recommended that the threshold for conversion to open procedures be lowered.A decade of experience with laparoscopic cholecystectomy (LC) has resulted in the liberalization of the indications for the procedure.Despite this experience, the incidence of injury to the extrahepatic biliary tree (approximately 1 injury per 200 cases), remains almost twice as high as that for an open procedure.This should concern surgeons, because when LC litigation data are compared with litigation data for open cholecystectomy (OC), it appears patients are much more willing to sue for an adverse outcome after LC.Regrettably, only 2 studies have examined the outcome of litigation involving LC.In the first study, Kernreviewed LC litigation data in a public database containing malpractice verdicts and settlements. He found 44 legal abstracts that demonstrated the distribution of adverse events that trigger litigation after LC were bile duct (27 cases [61%]), bowel (7 cases [16%]), vascular (4 cases [9%]), and miscellaneous (6 cases [14%]) injuries. The mortality rate associated with these events was 16%. Claims in the study by Kernwere closed in 25 cases (57%) and in the plaintiff's favor for an average of $438 000. In the second study, the Physician Insurers Association of America (PIAA)reviewed 324 LC claims. The PIAA, which represents more than 50 malpractice insurance companies that provide coverage for 60% of physicians,found that 67% of the claims filed after LC involved an injury to the biliary tree and that 83% of these injuries were not recognized at the time of surgery. Moreover, the PIAA observed that 50% of claims were settled in the plaintiff's favor for an average of $236 384.The data by Kernand, to a lesser degree, those of the PIAAreflect the “learning curve” years of LC, and thus may not be applicable to today's surgeons, who were formally trained in the laparoscopic technique. Neither of these studies attempted to correlate litigation outcome with mechanism of injury. Accordingly, the present study was undertaken to address these weakness.METHODSThe methodology used herein is virtually identical to that used by Kern,and it has been detailed elsewhere.Briefly, the LexisNexis database “Jury Verdict and Settlements, Combined” was searched for all cases containing the terms laparoscopy, bile, or gallbetween August 1, 1999, and August 31, 2004. Abstracts of each unique biliary surgery case identified were reviewed for patient demographics (age and sex) and type of injury (which were classified according to Kern's system). Bile duct injuries (BDIs) were then subclassified by the following mechanisms of injury: bile duct laceration (lacerations recognized intraoperatively, non–cystic duct bile accumulations, or leaks that presented postoperatively); ductal clippings (including traction or tent injuries of the confluence of the cystic, hepatic, and common bile ducts, as well as direct clip application to the right hepatic duct or the common bile duct [CBD]); cystic duct leaks; strictures of the extrahepatic biliary tree; and retained stones.Bile duct lacerations occurred with and without major vascular injuries. These injuries were distinctly different from vascular injuries that result from trocar insertion. For purpose of this analysis, when a vascular injury occurred in association with a bile duct laceration, it was classified as bile duct laceration. The remaining vascular injuries, which were all due to trocar insertion, were classified as vascular injuries.The bowel injury group consisted of injuries to the duodenum, and in all of these cases the actual mechanism of injury (eg, trocar or cautery) could not be determined. The miscellaneous group contained the remaining cases that were not otherwise classified. Thus, included in this group are 1 case of a preoperative error in judgment as well as intraoperative and postoperative complications that were not directly related to bile duct, vascular, or bowel injury. The miscellaneous group also includes 2 cases where the sole basis for the litigation appeared to be a prolonged postoperative course without a major adverse event related to negligence and 1 case where there was insufficient information for classification.Wherever possible, the data collected for the present study were compared with data published by Kernor the PIAA.Data are expressed as mean ± SD or mean (range). Finally, cases were classified according to intent to treat. Thus, LC cases that were converted to open procedures were analyzed as LC cases. Exploration of the CBD, which was always performed as an open procedure, was classified as an open procedure.RESULTSOne hundred twenty-two unique cases of elective biliary surgery litigation form the basis of this report (Table 1). Most of the cases involved LC; with only 8 cases involving the open technique (6 OCs and 2 CBD explorations). In 7 additional cases, there was insufficient information to determine whether the surgeon used the open or the laparoscopic technique. These 7 cases were classified as open. Surgeons were also named in 2 suits for T-tube removal and in 1 suit for failing to operate.Table 1. Summary of Why Surgeons Who Perform a Cholecystectomy Are SuedType of ProcedureNo. of ProceduresLC104Open8 OC6 CBD exploration2LC vs OC not distinguishable7T-tube removal2Failure to operate1Total122 Abbreviations: CBD, common bile duct; LC, laparoscopic cholecystectomy; OC, open cholecystectomy.Focus was then directed toward the 104 suits filed after LC (Table 2). Plaintiffs' demographics tended to reflect the demographics of patients who undergo elective LC in the private sector, ie, plaintiffs who sue their physicians tend to be middle-aged women. The most common event precipitating litigation was a BDI (61% in the Kern studyvs 78% in the present study). However, BDIs were caused by multiple mechanisms, including laceration, inappropriate clip application, and failure to secure the cystic duct. Not infrequently, BDI occurred because it was mistaken for the cystic duct. Miscellaneous misadventures were the second most frequent trigger for litigation (14% in the Kern studyvs 13% in the present study). Experience with LC has led to a decrease in the incidence of bowel and vascular injuries as litigation triggers (bowel injuries, 16% in the Kern studyvs 2% in the present study; vascular injuries, 9% in the Kern studyvs 7% in the present study). However, intraoperative injuries associated with LC continue to be frequently missed (86% in the present study vs 83% in the PIAA study). These missed injuries were associated with a high mortality rate (which was frequently related to sepsis) in patients who file suit (16% in the Kern studyvs 13% in the present study).Table 2. Plaintiff DemographicsPresent StudyKernNo. of plaintiffs10444Patient age, y, mean ± SD45.2 ± 6.7NAFemale, No. (%)94 (90)NAAdverse events, No. (%) Bile duct injury81 (78)27 (61)  Bile duct leak61 (68)  Cystic duct leak10 (10)  Clip21 (20)  Stricture1 (1)  Retained stone1 (1) Bowel injury2 (2)7 (16) Vascular injury7 (7)4 (9) Miscellaneous injury14 (13)6 (14)Injury not identified, No. (%)89 (86)83*Mortality, No. (%)14 (13)7 (16)Average payout, $508341438000 Abbreviation: NA, data not available. *Indicates data taken from Physician Insurers Association of America data.Given as a percentage.Two miscellaneous cases did not appear to have any specific adverse event to trigger litigation other than a prolonged hospital course. Regardless, being sued can be expensive. Kernfound that 57% of cases resulted in an average payment being made to plaintiffs of $438 000, which was echoed in the findings of the present study, where 60% of plaintiffs received $508 341 to end litigation, against single surgeon defendants.Because of the high prevalence of missed injuries, the decision to convert to an open procedure (hereafter referred to as convert-to-open) was reviewed in greater detail (Table 3). Overall, only 15% of the cases reviewed mention the decision to convert-to-open. In the 10 patients who received compensation (average, $570 956) despite the surgeon's decision to convert-to-open, in 60% of these cases the decisions to convert-to-open was made because of the need to fix an injury. Only 40% of convert-to-open decisions in this series were based on the surgeon's discretionary judgment that more exposure was necessary. A similar finding is observed in the 5 cases where a verdict favorable to the surgeon was returned (ie, litigation ended without any payment being made). In this group, there were 2 cases (40%) where the decision to convert-to-open was made only after an injury was recognized; in the remaining 3 cases (60%), the decision to convert-to-open was made to improve exposure.Table 3. Conversion to Open ProceduresFindingPlaintiffs' outcome No. of cases10 Indication, No. (%)  Discretion4 (40)  Fix a recognized injury6 (60) Average payout, $570956Surgeons' outcome No. of cases5 Indication, No. (%)  Discretion3 (60)  Fix a recognized injury2 (40)COMMENTRisk management has been defined as “a provider-based effort designed to reduce preventable injuries resulting from errors.”That is, risk management should be viewed as a process by which surgeons can improve their outcomes. Information collected in this study can be formulated into 5 risk management observations that could aid surgeon in avoiding being sued.OBSERVATION 1: MALPRACTICE SUITS ARE UNCOMMON AFTER OCLitigation after OC is uncommon, if not rare. As the gold standard for the management of biliary calculi,OC appears to be associated with a 50% lower incidence of BDIs.Moreover, the apparent lower incidence of BDIs after OCs compared with LCs is corroborated by the rising incidence of remedial biliary operations in many tertiary care centers.Such data suggest that OC is a safer operation.Therefore, it is not surprising that the only report of OC litigation in the literature could identify only 68 cases in a 20-year period.Similarly, the present study, using similar methodology to the study by Kern,found that in a 5-year period, only 15% of medical malpractice suits arising after cholecystectomy occurred after an open procedure. One could argue that this finding reflects the fact that LC has been the preferred surgical approach.However, such an argument would not explain the data from the studies by PIAAor Kern.(In particular, Kern's review of 44 cases of LC litigation identified during a 5-year period was performed in the early 1990s, when LC had not yet asserted its hegemony in the surgical armamentarium.) Thus, if a surgeon's sole goal is to minimize the risk of litigation after cholecystectomy, OC should be preferred over LC. (Admittedly, such a consideration may be incompatible with market realities and patients' desires.)OBSERVATION 2: FORMAL RESIDENCY TRAINING HAS NOT DECREASED THE PREVALENCE OF BDI IN LC LITIGATIONIn his seminal work on LC litigation, Kernwas optimistic about the future. Because most LC misadventures are the result of “preventable iatrogenic trauma or technical mishaps,”Kern hoped that LC misadventures would decrease over time because his data represented the “beginning of the laparoscopic learning curve.” Unfortunately, this hope seems to have only partially come true; despite more than a decade of formal residency training in LC, BDIs remain twice as common after LC than after OC.This observation suggests that systematic factors are operative in LC misadventures. Hughopined that the surgeon's spatial disorientation during LC was an important systematic factor that contributed to misadventures. Because of this misrecognition, Hugh noted that the traditional maxims for performing LC safely (the biliary structures must be adequately exposed; no structure is to be clipped or divided until it is clearly identified; and intraoperative cholangiography [IOC] should be routine) were not adequate to keep a surgeon out of trouble. Hughfound that LC misadventures could be substantially reduced if the operating surgeons would (1) always proceed from a fixed point of reference; (2) know their location at all times (by zooming the camera in and out); and (3) have a clear bearing on where the next several steps will take them. It is hard to truly know whether these recommendations, if incorporated into formal resident training, will improve the safety of LC. After all, Hugh's hospital is a high-volume tertiary care practice, and therefore his excellent results actually reflect his expertise.Still, Hughis to be congratulated for attempting to rethink how LC is taught and performed. Systematic analysis of surgical misadventure is an idea whose time has come, and all surgeons will soon benefit from ongoing research in system error reduction strategies.Other factors that, if incorporated into formal residency training, may decrease LC misadventures include the use of true stereoscopic vision afforded by a commercially available robotic surgical instrument (da Vinci surgical system; Intuitive Surgical, Mountain View, Calif)and increasing the use of automation.Admittedly, cost may be a barrier to implementing these techniques.OBSERVATION 3: ROUTINE IOC WILL NOT ELIMINATE LC LITIGATIONThe debate over whether IOC should be performed routinely or selectively during cholecystectomy was raging long before the laparoscopic technique was available. This report will not end the debate, but it will contribute to it by adding a legal slant. First, some commentators have stated that routine laparoscopic IOC “yields very little useful clinical information over what is obtained by selective policies.”Unfortunately, the studies used to support this conclusion focused on the use of IOC to eliminate retained stones and not on the identification of intraoperative BDIs. Second, in the present study, retained stones only rarely served as a litigation trigger. Thus, because the end point of IOC studies is the incidence of retained stones and because surgeons are rarely sued for retained stones, most of the literature on IOC is not relevant evidence when contemplating litigation.On the other hand, after reviewing Medicare's data on 1.6 million cholecystectomies, Flum et alopined that “the routine use of IOC may decrease the rate of CBD injury.” However, that article never said that the routine use of IOC would or could eliminate (or even substantially reduce) the number of BDIs that occur during LC. The reason Flum et aldid not make the latter statement was pointed out by the accompanying editorial by Talamini: Many BDIs occur when the CBD is confused with the cystic duct. Accordingly, BDIs often occur before a routine IOC would have been performed. Talamini's conclusionis supported by the present study, because many of the BDIs reported in the legal literature occurred because of misidentification of the CBD as the cystic duct, thereby resulting in the CBD being divided or clipped in preparation for an IOC.Still, routine performance of IOCs is not without potential value. A common denominator in LC litigation is that intraoperative injuries often go unnoticed. Intraoperative injuries were missed in 83% of cases in the PIAA studyand 86% of those in the present study. Because the vascular injuries are almost always readily recognized, the missed injury data suggest that virtually all BDIs are associated with a delay in diagnosis. Thus, if IOC were performed more frequently than 40% of LC cases,perhaps the number of cases that end up in court would decrease.Unfortunately, litigation avoidance is not so simple because, after an injury is recognized, the bile duct still needs to be repaired. However, because 75% of BDIs that are repaired at the time of the initial LC require subsequent revision,most patients with BDIs, even if recognized intraoperatively, require a remedial operation. Although patients may have some misgiving toward their surgeon when they learn that the surgeon had to repair a BDI during an elective LC, it is likely that these same patients will be very unhappy when they learn that the BDI will require a remedial operation.This unhappiness is something that drives litigation, especially because from the patient's point of view, a remedial operation is strike 3.For some time, it has been recognized that patients rarely sue their physicians after an adverse outcome.Generally, to be sued, a surgeon needs more than a single mistake and an adverse outcome; something more is required to get most people to file suit against their physicians. The “something else” could be a suboptimal interpersonal relationship with a patient, a devastating adverse event (eg, unanticipated paralysis), or the presence of multiple mistakes. Based on this review, many patients view conversion-to-open with dissatisfaction. That is, having forgotten that they were told that conversion-to-open was a possibility, plaintiffs often view conversion-to-open as strike 1 against the surgeon. A BDI would have been strike 2, and a suboptimally performed primary repair would therefore be strike 3. (Alternatively, the failure to identify injury intraoperatively could be strike 3.) Given that patients perceive BDIs as occurring because of a string of mistakes, it is not surprising that many of these patients become plaintiffs. In short, unless a BDI is expertly repaired so as to avoid a third strike, it is not clear that routinely performing an IOC will mitigate the potential for litigation.OBSERVATION 4: ROUTINE USE OF A DRAIN WILL NOT ELIMINATE LC LITIGATIONAs with IOC, the debate on mandatory drainage of the gallbladder fossa is not new, and this report is not going to provide the definitive answer. Still, one case abstract was interesting because a prominent biliary surgeon testified for the plaintiff that the failure to leave a drain constituted a deviation from the standard of care. This plaintiff's expert was willing to concede that a bile duct laceration was a recognized complication; however, the failure to place a drain, so as to detect the leak early, was substandard care. In this particular case, which was resolved in the plaintiff's favor, the diagnosis of a bile duct leak was delayed for several days. So even if the drain had been used and the leak detected sooner, the patient still would have required a remedial operation. From the patient's perspective, strike 1 was sustaining the injury, strike 2 was the surgeon's failure to recognize the injury during the procedure, and strike 3 would be the need for reexploration to treat the bile leak. Thus, as with the performance of a routine IOC, it is not clear that routinely leaving a drain after an LC will avoid litigation because it is likely that, from the patients' point of view, a remedial operation only arises after the surgeon has made several errors.OBSERVATION 5: LIBERALIZATION OF THE DECISION TO CONVERT-TO-OPEN MAY AVOID SOME LC LITIGATIONIn this series, the operating surgeon elected to convert-to-open in only 15% of the cases. This figure for conversion-to-open is certainly in the range of 1% to 30% that is reported in the literature.However, such statistics do not seem to tell the entire story. In more than half of the cases that underwent conversion-to-open in this series, the decision to convert was not made until the surgeon had recognized an injury. Thus, the decision to convert-to-open was mandated by intraoperative events and was not a discretionary decision to obtain better exposure or facilitate mobilization of the right upper quadrant.The textbook by the American College of Surgeons, however, states:Ideally, the surgeon should wish to convert before any complication occurs. It must be emphasized that conversion to open surgery should not be considered a failure or a complication. Rather, it should be considered a prudent maneuver for achieving the desired objective—namely, safe removal of the gall bladder.(p467)This seems like prudent advice. If the trigger to open a patient during surgery were liberalized (ie, the threshold to convert-to-open was lowered), it is reasonable to conclude that fewer BDIs would occur. Whether this is because the 2-dimensional view of the typical laparoscopic imaging system is suboptimal, or because Hughis correct that the laparoscopic technique is associated with increased spatial disorientation of the surgeon, the fact remains that fewer BDIs occur during OC. For surgeons who perform LC and wish to avoid litigation, the trick appears to be to make the decision to convert-to-open before an injury occurs and a bile duct needs to be repaired. True, some patients may perceive conversion-to-open with dissatisfaction. However, patients who are only dissatisfied rarely sue their surgeons.Thus, if a surgeon converts-to-open and the rest of the case proceeds well, such that the surgeon avoids adverse strikes 2 (iatrogenic injury) and 3 (remedial operation), it is much less likely that the surgeon will be sued.LIMITATIONSObservations are only as good as the data on which they are built. A Wall Street Journalarticleobserved that finding quality data on medical malpractice litigation is difficult. The reason that quality malpractice data are lacking is multifactorial. Although the Journalis correct that “corporate shield” clauses compromise the data within the National Practitioner Data Bank by concealing the identity of wayward physicians, it is equally true that the National Practitioner Data Bank data are skewed because they only contain information on physicians' adverse outcomes.In addition, there are 3 other limitations to reviewing medical malpractice limitation from legal data banks. First, legal data banks, such as used by Kernand herein, contain only a small sample of all LC malpractice claims. Second, legal data banks have 2 levels of case selection bias: selection bias at the submitter level and at the journal level for cases that are newsworthy. Thus, reported cases tend to be those cases where one side was perceived to have achieved a clear victory. Third, legal database studies included negotiated settlements and verdict awards. A negotiated settlement is a hard figure that is not ordinarily subject to further change. On the other hand, jury awards are an elusive figure. After a trial is over, many procedural avenues are available for physicians to challenge an excessive jury award.CONCLUSIONSLitigation is much more common after LC than OC. There appear to be 2 reasons for this finding. First, BDIs are more common with LC; second, intraoperative injuries are missed in most litigated LC cases. How to improve the outcomes associated with LC is not obvious, because it appears that formal residency training and routine use of IOC do not eliminate a substantial number of BDIs. Accordingly, it is recommended that surgeons lower their threshold to convert-to-open during LC. In particular, if a surgeon wishes to avoid litigation, the decision to convert-to-open should be made early in the procedure to prevent an intraoperative misadventure and not to repair an injury.Correspondence:Thomas R. McLean, MD, JD, Surgical Service, Eastern Kansas Veterans Affairs Health Care System, 4101 S Fourth St Trafficway, Leavenworth, KS 66048 ([email protected]).Accepted for Publication:June 7, 2005.Disclaimer:Nothing in this article is to be construed as US Department of Veterans Affairs policy, procedure, or endorsement.Acknowledgments:The author thanks Chris C. Haller, MD, Service Line Director, Eastern Kansas Veterans Affairs Health Care System, and Edward P. Richards, JD, Louisiana State University School of Law, Baton Rouge, for reviewing this report.REFERENCESJASheaJABerlinDRBachwichIndications for and outcomes of cholecystectomy: a comparison of pre and postlaparascopic eras.Ann Surg19982273433509527056JJEscarceWChenJSSchwartzFalling cholecystectomy thresholds since the introduction of laparoscopic cholecystectomy.JAMA1995273158115857745770JMSarmientoMBFanellDMNagorneyDOHodgeJRHarringtonQuality-of-life assessment of surgical reconstruction after laparoscopic cholecystectomy–induced bile duct injury.Arch Surg200413948348915136347RMWalshJMHendersonDPVogtTrends in bile duct injuries from laparoscopic cholecystectomy.J Gastrointest Surg199824584629843606Physicians Insurers Association of AmericaLaparoscopic injury study, August 2000.http://www.piaa.us/downloads/order_forms.htm. Accessed January 2005KAKernMalpractice litigation involving laparoscopic cholecystectomy: cost, causes, and consequences.Arch Surg19971323923979108760Physicians Insurers Association of AmericaWhat is PIAA?http://www.thepiaa.org/about_piaa/what_is_piaa.htm. Accessed January 2005TRMcLeanMonetary lesson from litigation involving laparoscopic cholecystectomy.Am Surg20057160661216089128BALiangThe effectiveness of physician risk management: potential problems for patient safety.Risk Decis Policy20005183202CKMcSherryCholecystectomy: the gold standard.Am J Surg19891581741782672837ZQHuangXQHuangChanging patterns of traumatic bile duct injuries: a review of forty years experience.World J Gastroenterol2002851211833062RMWalshDPVogtJLPonskyManagement of failed biliary repairs for major bile duct injuries after laparoscopic cholecystectomy.J Am Coll Surg200419919219715275872KAKernMedicolegal analysis of bile duct injury during open cholecystectomy and abdominal surgery.Am J Surg19941682172228080055GGGhahremaniPostsurgical biliary tract complications.Gastroenterologist1997546579074919TBHughNew strategies to prevent laparoscopic bile duct injury—surgeons can learn from pilots.Surgery200213282683512464867KAKernResearching errors in surgery: five analytic tools borrowed from industry.Focus Patient Saf19992(3)3http://www.npsf.org/download/Focus1999Vol2No3.pdf. Accessed January 2005TRMcLeanCybersurgery: an argument for enterprise liability.J Leg Med20022316721012079590TDrasinEDutsonCGarciaUse of a robotic system as surgical first assistant in advanced laparoscopic surgery.J Am Coll Surg200419936837315325605TRMcLeanAutomatic cybersurgery: innovation or a means to close community hospitals and displace physicians?John Marshall J Comput Inf Law200220495536MSMetcalfeTOngMHBrueningHIswariahSAWemyss-HoldenGJMaddernIs laparoscopic intraoperative cholangiogram a matter of routine?Am J Surg200418747548115041494DRFlumEPDellingerACheadleLChanTKoepsellIntraoperative cholangiography and the risk of common bile duct injury during cholecystectomy.JAMA20032891639164412672731MATalaminiRoutine vs selective intraoperative cholangiography during cholecystectomy.JAMA20032891691169212672738WCChapmanAJHerlineJPDebelakBile duct injury following laparoscopic cholecystectomy [abstract].Dig Dis Week. 1999. Abstract 2071. http://www.ssat.com/cgi-bin/abstracts/99ddw/ddw4.cgi?affiliation=other. Accessed January 2005ARLocalioAGLawtherTABrennanRelationship between malpractice claims and adverse events due to negligence: results of the Harvard Medical Practice Study III.N Engl J Med19913252452512057025TRMcLeanWhy do physicians who treat lung cancer get sued?Chest20041261672167915539742GMFriedLSFeldmanDRKlassenLaparoscopic cholecystectomy.In: Souba WW, Fink MP, Jurkovich GJ, Kaiser LR, eds. ACS Surgery: Principles & Practice. New York, NY: WebMD Professional Publishing; 2004:chap 15JTHallinanDoctor is out: attempt to track malpractice cases is often thwarted.Wall Street J. August 27, 2004:A1JEFischerThe current status of the National Practitioner Data Bank.Bull Am Coll Surg200186(9)2024, 47

Morgenstern, Leon

doi: 10.1001/archsurg.141.7.648pmid: N/A

Among the figures given by McLean, one number cited by him stands out by its sheer enormity. It is the number of BDIs incurred during LC, quoted at the rate of 1 injury per 200 cases. Given the large number of cholecystectomies performed annually in the United States (500 000-750 000), we should expect more than 15 000 cases of BDI in a 5-year period. McLean draws his conclusions from an analysis of only 104 cases, derived from litigation statistics. This is a very small fraction of the total case incidence. Can his observations be valid based on that small sample? There is no disputing his first observation that the landscape of litigation concerning BDI has been changed radically by LC. His second observation that formal training has not decreased the prevalence of litigation is less evident, in my opinion, in this small heterogeneous sample. His third observation that routine intraoperative cholangiography will not eliminate LC litigation is probably true, but the implications can be misleading. Intraoperative cholangiography is useful for disclosure of residual stones, but it is equally important for delineation of biliary tract anatomy and detection of operative injury.1-3 I believe the preponderance of evidence is that intraoperative cholangiography is useful in lessening BDI and in identifying it once it has occurred. It would be the height of folly to discourage intraoperative cholangiography merely because it does not appear to influence litigation. I heartily agree with his fifth observation on timely conversion of LC to an open procedure. Better exposure in difficult situations can not only avert BDI but also detect those injuries amenable to repair. On both counts, it is a way out when “the going gets rough.” I once dubbed the hesitancy to convert in timely fashion “surgical hubris.” I applaud McLean's assiduous quest for the root causes of BDI in LC. His small case sampling points out an inherent defect in our reporting system. Information from current data banks is woefully inadequate, an ironic defect in this age of informatics. Laparoscopic cholecystectomy is here to stay, despite BDI and litigation risks. Good practice demands training, competence, evidence-based techniques, judgment, and recognition of risks, probably the least of which should be litigation. Correspondence: Dr Morgenstern, Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Becker Building, Suite 216, Los Angeles, CA 90048 ([email protected]). References 1. Woods MSTraverso LWKozarek RA et al. Characteristics of biliary tract complications during laparoscopic cholecystectomy: a multi-institutional study. Am J Surg 1994;16727- 32PubMedGoogle ScholarCrossref 2. Fletcher DRHobbs MSTTan R et al. Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study. Ann Surg 1999;229449- 457PubMedGoogle ScholarCrossref 3. Flum DRDellinger EPCheadle AChan LKoepsell T Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA 2003;2891639- 1644PubMedGoogle ScholarCrossref

Ishizaki, Yoichi; Yoshimoto, Jiro; Miwa, Ken; Sugo, Hiroyuki; Kawasaki, Seiji

doi: 10.1001/archsurg.141.7.649pmid: 16847234

BackgroundIt has recently been demonstrated that the liver parenchyma is more tolerant to intermittent pedicular clamping than to continuous pedicular clamping. However, the possibility of increased blood loss during intermittent reperfusion is a major concern.DesignWe retrospectively selected 34 cases in which the cumulative clamping time was 90 minutes or longer during hepatectomy and the intermittent Pringle maneuver was applied rather than continuous inflow occlusion.PatientsResections were performed for metastatic carcinoma in 19 patients, hepatocellular carcinoma in 7 patients, hilar bile duct carcinoma in 3 patients, intrahepatic cholangiocarcinoma in 1 patient, combined hepatocellular carcinoma and cholangiocarcinoma in 1 patient, undifferentiated embryonal sarcoma in 1 patient, carcinoid tumor in 1 patient, and benign mucinous cystic tumor in 1 patient. Patients were categorized on the basis of the cumulative clamping time, with 25 patients in group 1 (≤120 minutes) and 9 patients in group 2 (>120 minutes). In 2 patients in group 2, the cumulative clamping time exceeded 240 minutes. Twenty-eight patients had histologically normal underlying liver parenchyma; 6 patients had chronic hepatitis or cirrhosis.ResultsNo red blood cell transfusions were required in group 1; blood transfusions were needed for only 3 patients in group 2. There was no postoperative mortality or major complications. The rate of minor postoperative complications was 36% (9 patients) in group 1 and 22% (2 patients) in group 2.ConclusionsProlonged intermittent pedicular clamping is a useful maneuver in hepatectomy when resection is difficult or prolonged or when the liver parenchyma is abnormal. Such clamping can be used for cumulative periods exceeding 120 minutes without major intraoperative blood loss or complications.Although most liver resections are performed with an inflow occlusion time of less than 90 minutes, longer periods of hepatic ischemia have sometimes been required to accomplish complicated and extensive hepatectomies for malignant neoplasms, such as multiple resections, caudate lobectomy, or hepatectomies with vascular reconstruction. The intermittent Pringle maneuver (IPM) has been applied to avoid ischemic injury induced by prolonged inflow occlusion.However, many Western surgeons are still reluctant to use intermittent pedicular clamping because of the associated risk of increased blood loss during the reperfusion period.A clinical controlled trial demonstrated that the liver parenchyma is more tolerant to intermittent pedicular clamping than to continuous pedicular clamping.In these studiesof intermittent clamping, a total occlusion time of less than 90 minutes was used, and the safe upper time limit for total occlusion was not defined. The present study was performed to evaluate the course of patients who underwent hepatectomy with a cumulative intermittent inflow occlusion time of 90 minutes or longer to determine the benefits of such clamping and the tolerance of the liver parenchyma to clamping.METHODSBetween October 1, 2002, and December 30, 2004, 157 patients underwent hepatic resection using the IPM. We retrospectively selected 34 patients in whom the cumulative clamping time was 90 minutes or longer. There were 27 men and 7 women, with a mean age of 61.1 years (age range, 21-84 years). In the remaining 123 patients, the cumulative ischemic time was less than 90 minutes.Resections were performed for malignant hepatic tumors in 33 patients and for a benign mucinous cystic tumor in 1 patient. The malignant tumors included 19 metastatic carcinomas, 7 hepatocellular carcinomas, 3 hilar bile duct carcinomas, 1 intrahepatic cholangiocarcinoma, 1 combined hepatocellular and cholangiocarcinoma, 1 undifferentiated embryonal sarcoma, and 1 carcinoid tumor.The liver parenchyma was abnormal in 6 of 34 patients because of chronic hepatitis or cirrhosis associated with hepatitis B or C viral infection. The 3 patients with hilar bile duct carcinoma had obstructive jaundice and underwent biliary drainage before liver resection. Preoperative portal vein embolization was carried out in 2 patients whose ratio of the nontumorous parenchymal volume of the resected liver to that of the whole liver exceeded 60%. Major resections (≥1 sector) were performed in 27 patients (79.4%), multiple limited resections in 4 patients (11.8%), and single segmentectomy in 3 patients (8.8%) (Table 1). Twelve patients with small, bilateral, and multiple hepatic tumors required major hepatic resection with additional limited resection of the remnant liver.Table 1. Types of Operative Procedures Among 34 PatientsType of ResectionWith Limited ResectionWithout Limited ResectionTotalMajor resection Right hepatectomy347 Extended right hepatectomy235 Right lateral hepatectomy224 Extended right lateral hepatectomy112 Left hepatectomy314 Extended left hepatectomy101 Left trisegmentectomy022 Right trisegmentectomy011 Median hepatectomy011Simple segmentectomy. . .. . .3Multiple limited resections. . .. . .4PREOPERATIVE ASSESSMENTBlood tests were performed before surgery in all patients and included complete blood cell count, coagulation profile with prothrombin time, indocyanine green retention rate at 15 minutes, and routine liver biochemical tests, including the serum levels of total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT).SURGICAL PROCEDUREJ-shaped and inverted T-shaped incisions were used. The operative field was kept open using Kent retractors (Takasago Co Ltd, Tokyo) throughout the operation. In some cases, the J-shaped incision was extended to the ninth intercostal space. Under intraoperative ultrasonographic guidance, the area to be resected was defined, the transection line was monitored, and the tumor was removed.The IPM was applied at the time of liver transection and consisted of cross-clamping the hepatoduodenal ligament using a Satinsky clamp (and the aberrant left hepatic artery, if present) for 15 minutes and releasing the clamp for 5 minutes until the liver resection was completed. Cooling of the liver with topical refrigeration or hypothermic perfusion was not used. Liver transection was performed in all patients using the traditional clamp crushing method. A small amount of the hepatic parenchyma was divided by penetration using a Péan forceps. The remaining side of the parenchyma was ligated and divided using scissors; any bleeding or bile leakage points were fine sutured.POSTOPERATIVE ASSESSMENTPostoperative variables of hepatocyte damage and recovery, including serum AST, ALT, and total bilirubin levels, were measured every day during the first week after the operation and twice during the second week. All accumulated abdominal fluids were drained percutaneously and sent for bacterial culture; the serum total bilirubin level was monitored to detect any biliary leakage. We diagnosed biliary leakage when the drainage fluid was found to contain a serum total bilirubin concentration of more than 3 times the upper normal limit in serum after surgery. The postoperative hospital stay was defined as the period between surgery and discharge.The overall mean ± SD duration of cumulative clamping in the 34 study subjects was 120 ± 48 minutes (range, 90-325 minutes). These 34 patients were divided into 2 groups according to the cumulative period of occlusion. Patients in group 1 (n = 25) underwent inflow occlusion for 90 to 120 minutes (mean ± SD cumulative clamping time, 99.4 ± 8.4 minutes). Patients in group 2 (n = 9) underwent inflow occlusion for longer than 120 minutes (mean ± SD cumulative clamping time, 176.1 ± 68.0 minutes).The 2 groups were compared using the bilateral ttest for quantitative variables and the &khgr;2test or Fisher exact test for qualitative variables. Continuous variables were expressed as mean ± SD, and differences at P<.05 were considered statistically significant. Calculations were made using StatView computer software (SAS Institute Inc, Cary, NC).RESULTSGroups 1 and 2 were matched for age, sex, preoperative liver function test data, status of underlying liver disease, and number of viral hepatitis infections (Table 2). The 2 patients who underwent extended right lobectomy after preoperative portal vein embolization were fitted into group 1. In 2 patients, the cumulative clamping time exceeded 240 minutes. In the patient with the longest cumulative period of hepatic ischemia (325 minutes), the IPM was repeated 19 times to accomplish complete resection of a huge carcinoid tumor situated close to the hepatic veins and inferior vena cava (Figure). The intraoperative blood loss was 3820 mL during left trisegmentectomy, and the intraoperative blood transfusion volume was 1390 mL. The other patient, who had 11 bilobar hepatic metastatic tumors, underwent left hepatectomy and 8 limited resections. The IPM was repeated 16 times to accomplish complete resection of the multiple tumors, and the cumulative period of hepatic ischemia was 250 minutes. The intraoperative blood loss was 770 mL, and no blood transfusion was given. No obvious visceral congestion was recognized during the period of clamping in either of the patients. The postoperative course of both patients was uneventful.Figure.Computed tomographic scans showing a huge tumor consisting of solid and cystic components. A, Computed tomographic scan showing a huge tumor involving the left lobe and the anterior segment of the right lobe. B, Tumor consisting of solid and cystic components compresses the right hepatic vein. C, Caudal part of the tumor is adjacent to the right portal pedicle.Table 2. Characteristics of the 34 Patients Undergoing Resection With Prolonged Intermittent Pedicular Clamping*CharacteristicGroup 1(n = 25)Group 2(n = 9)PValueDemographics Age, y62 ± 1360 ± 8.49 Male-female ratio18:79:0.19Preoperative laboratory tests Indocyanine green retention   rate at 15 min, %11.1 ± 5.111.5 ± 5.6.85 Prothrombin time, %92 ± 896 ± 5.13 Aspartate aminotransferase, U/L32 ± 1440 ± 22.23 Alanine aminotransferase, U/L37 ± 3037 ± 25.98 Total bilirubin, mg/dL0.76 ± 0.340.79 ± 0.34.83Histology of nontumorous liver,  No. (%)  Chronic liver disease4 (16.0)2 (22.2)<.99  Hepatitis viral infection4 (16.0)3 (33.3).53 SI conversion factor: To convert bilirubin to micromoles per liter, multiply by 17.1. *Data are given as mean ± SD unless otherwise indicated.Overall, the mean ± SD intraoperative blood loss was 1022 ± 687 mL (range, 175-3820 mL). The mean ± SD intraoperative blood loss in group 1 (883 ± 461 mL) was significantly lower than that in group 2 (1409 ± 1039 mL). We used the hematocrit as an indicator of transfusion requirements and carried out transfusion when the hematocrit was lower than about 25%. Red blood cell transfusion was necessary in only 3 patients (33.3%) in group 2. No patient in group 1 required red blood cell transfusion. No patient required postoperative red blood cell transfusions in either group. The mean ± SD duration of surgery in group 1 (179 ± 49 minutes) was significantly shorter than that in group 2 (665 ± 237 minutes). Group 2 included 3 patients with hilar bile duct carcinoma who underwent extended lobectomy. These patients required concomitant biliary reconstruction. In the 123 patients in the original cohort with a cumulative clamping time of less than 90 minutes, the mean ± SD blood loss during surgery was 450 ± 336 mL, and 3 (2.4%) of these patients had blood transfusion. Although 4 patients in group 1 and 2 patients in group 2 had chronic liver disease associated with viral hepatitis (their mean ± SD indocyanine green retention rate at 15 minutes was significantly higher than that in the 28 patients with normal liver; 16.5% ± 2.5% vs 9.9% ± 4.8%, P = .003), their intraoperative blood loss was not significantly higher than that in the 28 patients with a normal liver (987 ± 560 vs 1030 ± 720 mL, P  = .89). Only 1 patient with cirrhosis in group 2 required red blood cell transfusion.The postoperative maximum levels of AST and ALT in the patients in group 2 were significantly higher than those in the patients in group 1. There was no significant difference in the maximum serum total bilirubin levels between the groups (Table 3). The AST level in group 1 returned to the preoperative value at a mean ± SD of 6.4 ± 2.7 days after the operation, whereas in group 2 it did so at 9.7 ± 7.6 days after the operation (P = .07). The ALT level in group 1 returned to the preoperative value at a mean ± SD of 9.5 ± 3.9 days after surgery, whereas in group 2 it did so at 13.7 ± 4.3 days after the operation (P = .01).Table 3. Effects of the Duration of Liver Ischemia*EffectGroup 1(n = 25)Group 2(n = 9)PValueMean cumulative pedicle clamping time, min99.4 ± 8.4†176.1 ± 68.0‡Blood loss during operation, mL883 ± 4611409 ± 1039.047Blood transfusion during operation, No. of patients03.02Operative time, min489 ± 171665 ± 237.02Postoperative maximum total bilirubin, mg/dL1.91 ± 1.221.51 ± 0.83.38Postoperative maximum aspartate aminotransferase, U/L410 ± 324966 ± 590.001Postoperative maximum alanine aminotransferase, U/L383 ± 350913 ± 690.006Recovery interval of aspartate aminotransferase, d6.4 ± 2.79.7 ± 7.6.07Recovery interval of alanine aminotransferase, d9.5 ± 3.913.7 ± 4.3.01Postoperative complication, No. (%)9 (36.0)2 (22.2).73Inhospital death, No. (%)00. . .Postoperative hospital stay, d32.7 ± 17.028.0 ± 4.7.42 SI conversion factor: To convert bilirubin to micromoles per liter, multiply by 17.1. *Data are given as mean ± SD unless otherwise indicated. †Range, 90 to 118 minutes. ‡Range, 122 to 325 minutes.There was no postoperative mortality among the 34 patients who underwent prolonged multiple intermittent portal triad clamping. The overall morbidity was 32% (11 patients). No major complications (including postoperative liver failure) occurred, and no patient required reoperation. The morbidity in group 1 was 36% (9 patients), whereas that in group 2 was 22% (2 patients) (P = .73). There were 17 minor complications in 11 patients, and there were no potentially fatal complications. There were 7 cases of bile leakage, all of which resolved spontaneously within 3 weeks. Five patients developed wound infection that was diagnosed by positive culture of microorganisms from the wound, 2 patients developed right-sided pleural effusion, 1 patient experienced prolonged lymphorrhea, 1 patient had delayed gastric emptying, and 1 patient experienced diarrhea. All complications were cured with conservative treatment. The postoperative hospital stay was similar in both groups. Only 1 of 6 patients with chronic liver disease developed wound infection, which was cured by drainage and administration of antibiotics. The overall 1-year survival rates after hepatectomy were virtually the same in the 2 groups: 89% (23 patients) in group 1 and 88% (8 patients) in group 2.COMMENTUncontrollable massive hemorrhage can lead to deterioration of liver function and increased postoperative mortality and morbidity. At the beginning of the 20th century, Pringledemonstrated that inflow vascular occlusion could reduce the degree of liver bleeding. His observation that vascular control could enable major hepatic resection without excessive blood loss predated the progressive decrease in mortality and morbidity associated with liver resection that has occurred during the past 50 years, largely as a result of lower intraoperative blood loss.Hannoun et alreported that continuous vascular occlusion during major hepatic surgery is a useful maneuver that may be performed safely on normal hepatic parenchyma for up to 90 minutes. Kim et aldemonstrated that prolonged continuous hepatic inflow occlusion could be used during hepatectomy for up to 75 minutes without serious complications in selected patients with active chronic liver disease. Despite the widespread use of continuous vascular clamping during major hepatic resection, concern arose that ischemia followed by reperfusion associated with vascular clamping could cause injury to the liver.To improve hepatic parenchymal tolerance to ischemia, intermittent inflow occlusion has gained wide popularity, particularly in Asia.Various protocols have been recommended using periods of inflow occlusion for 10 to 30 minutes followed by 5 to 15 minutes of reperfusion. Elias et aldemonstrated that the IPM results in less blood loss and better preservation of liver function and permits a total ischemia time of up to 120 minutes. A randomized clinical study of patients undergoing liver resection by Belghiti et alshowed that intermittent clamping using multiple cycles of 15 minutes of ischemia and 5 minutes of reperfusion was associated with decreased injury compared with similar periods of continuous inflow occlusion. The previously reported maximum limit of normothermic cumulative hepatic ischemia using intermittent clamping was 322 minutes.Our clinical data show that the safe upper limit of cumulative hepatic ischemia in normal liver can be extended to 325 minutes without major complications.On the other hand, there is always a risk of ischemic damage to hepatocytes, especially in patients with chronic liver disease, the degree of which is likely to be accentuated by a prolonged period of vascular inflow occlusion.Within tolerable periods of ischemia, the liver can recover from operative and ischemic injury. Otherwise, deterioration of liver function will ensue. The present study revealed that prolonged intermittent pedicular clamping does not increase operative mortality and morbidity even in patients with chronic liver disease. Selected patients with cirrhotic liver withstood prolonged intermittent ischemia for up to 142 minutes, a period within which any difficult hepatectomy can be safely accomplished without excessive bleeding.The concept of ischemic preconditioning has been applied recently to hepatic surgery and is based on the biological principle that tissue primed by various types of sublethal stress develops tolerance to subsequent lethal injury.Clavian et alprovided evidence that a preconditioning period of 10 minutes followed by 10 minutes of reperfusion confers protection against prolonged ischemic insults in patients undergoing liver resection. Ischemic preconditioning is superior for ischemic periods of up to 75 minutes because it is not associated with blood loss during transection of the liver. Multiple short ischemia-reperfusion cycles were less deleterious than 1 continuous period of the same duration, suggesting that some of the benefit of intermittent pedicle clamping may actually result from the effect of the first clamp-unclamp sequence as a preconditioning treatment. Further studies in this area are encouraged.Pedicle inflow occlusion induces liver ischemia and subsequent changes in the serum aminotransferase levels.The present study confirmed that there was significant correlation between the maximum postoperative aminotransferase levels and the duration of ischemia (AST r = 0.681 and ALT r = 0.694, P<.001 for both), but changes in the serum enzyme levels were always transient, with a tendency to return toward the preoperative level within a week. On the other hand, liver ischemia is not the only factor responsible for aminotransferase release. Surgical trauma probably contributes considerably to this, as suggested by the 8-fold increase in the serum aminotransferase levels seen after hepatectomy performed without vascular occlusion.The amount of liver resected has been linked to the rise of aminotransferase after hepatectomy.During left or right hepatectomy, the branches of the hepatic artery and portal vein of the resected lobe are divided initially. In cases of limited resection, the glissonian triad that feeds the resected area is ligated first. Aminotransferase release into the systemic circulation from these ischemic tissues continues until the vein draining the resected area is ligated. Therefore, the postoperative serum aminotransferase levels after hepatectomy may reflect not only the degree of ischemic damage to the residual liver but also the aminotransferase released from the resected liver.Drawbacks associated with intermittent occlusion include increased duration of surgery and blood loss from the transected surface of the liver during the successive periods of reperfusion.The minimization of intraoperative blood loss and the consequent lack of necessity for blood transfusion is a widely accepted goal, because these factors impair patient outcome and prognosis. In the 123 patients in the original cohort with a cumulative clamping time of less than 90 minutes, the blood loss during surgery was low and only 3 patients required blood transfusion; most of the 34 patients with a cumulative ischemic time of 90 minutes or longer also had no significant blood loss and only 3 patients required blood transfusion. Because a transfusion rate of up to 30% is generally considered acceptable,our findings in the present series of difficult hepatectomies demonstrate that good results can be achieved with intermittent pedicular clamping. To obtain a bloodless operative field, liver dissection was accomplished using Péan forceps.Careful millimeter-by-millimeter progression is mandatory, with ligation of every thin vascular or biliary structure. The minimization of backbleeding from accidentally injured hepatic veins is another way of reducing the need for blood transfusion; to achieve this, reducing the inferior vena caval pressure by administering a muscle relaxant and reducing the tidal volume seem to be adequate. Moreover, to prevent liver congestion, the division of the glissonian triad of the partial liver to be resected preceded that of the hepatic vein. The hepatic veins were ligated on the nonresected side and were clipped on the specimen side.Our retrospective study of these 34 cases in which intermittent portal triad clamping of 90 minutes or longer was used showed no postoperative mortality and acceptable minor complications. This study highlights the usefulness of intermittent pedicular clamping in terms of parenchymal tolerance to ischemia. Intermittent pedicular clamping allows an increase in the cumulative ischemic time and the performance of difficult hepatectomies without increasing the amount of blood loss or significant postoperative liver dysfunction, even in patients with histologically abnormal liver parenchyma.Correspondence:Yoichi Ishizaki, MD, Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan ([email protected]).Accepted for Publication:June 14, 2005.REFERENCESMMakuuchiTMoriPGunvénSYamazakiHHasegawaSafety of hemihepatic vascular occlusion during resection of the liver.Surg Gynecol Obstet19871641551583810429KManSTFanIOLNgCMLoCLLiuJWongProspective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study.Ann Surg19972267047139409569CHuguetAGavelliSBonaHepatic resection with ischemia of the liver exceeding one hour.J Am Coll Surg19941784544588167881GNuzzoFGiulianteIGiovanniniGDTebalaGCosmoHepatic resections in normothermic ischemia.Surgery19961208528588909521JBelghitiRNounRMalafosseContinuous versus intermittent portal triad clamping for liver resection.Ann Surg199922936937510077049JHPringleNotes on the arrest of hepatic haemorrhage due to trauma.Ann Surg190848541549LHannounDBorieEDelvaLiver resection with normothermic ischaemia exceeding 1h.Br J Surg199380116111658402122YIKimKNakashimaITadaKKawanoMKobayashiProlonged normothermic ischaemia of human cirrhotic liver during hepatectomy: a preliminary report.Br J Surg199380156615708298928FSSerrasino-InglottNAHabibRTMathieHepatic ischemia-reperfusion injury.Am J Surg200118116016611425059DEliasEDesruennesPLasserProlonged intermittent clamping of the portal triad during hepatectomy.Br J Surg19917842441998862YSakamotoMMakuuchiTTakayamaMMinagawaYKitaPringle's maneuver lasting 322 min.Hepatogastroenterology199946457458CPeraltaNPratsCXausEGelpíJRCatafauProtective effect of liver ischemic preconditioning on liver and lung injury induced by hepatic ischemia-reperfusion in the rat.Hepatology1999301481148910573528PAClavienSYadavDSindramRCBentleyProtective effects of ischemic preconditioning for liver resection performed under inflow occlusion in humans.Ann Surg200023215516210903590BSucYPanisJBelghitiFFékétéNatural history of hepatectomy.Br J Surg19927939421346582HEkbergKGTranbergRAndersonBJeppssonSBengmarkMajor liver resection: perioperative course and management.Surgery1986100173014674OAlmersjoSBengmarkLOHafstromROlssonEnzyme and function changes after extensive liver resection in man.Ann Surg19691691111195762442GGozzettiAMazziottiGLGraziLiver resection without blood transfusion.Br J Surg199582110511107648166DMarietteCSmadajaSNaveauGBorgonovoCVonsDFrancoPreoperative predictors of blood transfusion in liver resection for tumor.Am J Surg19971732752799136779TTakayamaMMakuuchiKKubotaRandomized comparison of ultrasonic vs clamp transection of the liver.Arch Surg2001136922928

Fabian, Timothy C.

doi: 10.1001/archsurg.141.7.654pmid: N/A

In this issue of the ARCHIVES, Ishizaki et al1 report a remarkable series of 34 complex liver resections (see their Table 1) for a variety of metastatic and primary malignant neoplasms (1 case involved benign disease). The crux of this retrospective review was to demonstrate not the safety and efficacy of their technique of liver resection but its superiority. They use the IPM (15 minutes of occlusion followed by 5 minutes of reperfusion) throughout the hepatic resection. They note that, while this technique is used in Asia, it is not widely accepted in the West primarily because of concerns about excessive blood loss. The purported advantage of the technique is that it ameliorates ischemia-induced hepatocellular injury. A novel aspect of their article is that their study analyzes results for complex resections with occlusion times of 90 minutes or longer, while previous studies2-4 used intermittent portal triad occlusion for less than 90 minutes. They subdivide the population into 2 cohorts: group 1 consisting of 25 patients with occlusion times of 90 to 120 minutes and group 2 consisting of 9 patients with occlusion times exceeding 120 minutes. Their results are indeed outstanding. They had no operative deaths, no reoperations, and no major complications, with a 1-year survival rate of 89%. While these results may be associated with the IPM, they are also likely a result of the authors' large experience and meticulous surgical technique. During the 27-month study period, they performed 157 hepatic resections (123 with occlusion times <90 minutes). They performed dissection using Péan forceps rather than ultrasonic dissection, and their operative times averaged 8 and 11 hours in groups 1 and 2, respectively. A factor that speaks to the safety of the IPM in their hands, to their surgical technique, and perhaps to the excellent outcomes is the remarkable scarcity of blood transfusions administered. Only 3 (8.8%) of 34 complex resections required transfusions, and only 3 (2.4%) of 123 resections with an IPM of less than 90 minutes required blood transfusions. I would postulate that avoidance of transfusions substantially contributed to their results. In recent years, a large body of research has accumulated demonstrating that transfusions produce acute lung injury and immunosuppression; as the authors suggest, the IPM probably decreases ischemia-induced injury, especially in cases requiring prolonged occlusion. However, I have a suspicion that drastically minimizing transfusions helped a great deal. In the future, it is likely that avoidance of transfusion through more restrictive transfusion strategies and the development of blood substitutes will significantly improve the outcomes of all major surgical procedures. Correspondence: Dr Fabian, Department of Surgery, College of Medicine, University of Tennessee, 956 Court Ave, Suite G228, Memphis, TN 38163 ([email protected]). References 1. Ishizaki YYoshimoto JMiwa KSugo HKawasaki S Safety of prolonged intermittent Pringle maneuver during hepatic resection. Arch Surg 2006;141649- 654Google ScholarCrossref 2. Makuuchi MMori TGunvén PYamazaki SHasegawa H Safety of hemihepatic vascular occlusion during resection of the liver. Surg Gynecol Obstet 1987;164155- 158PubMedGoogle Scholar 3. Man KFan STNg IOLLo CMLiu CLWong J Prospective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study. Ann Surg 1997;226704- 713PubMedGoogle ScholarCrossref 4. Belghiti JNoun RMalafosse R et al. Continuous versus intermittent portal triad clamping for liver resection. Ann Surg 1999;229369- 375PubMedGoogle ScholarCrossref

Salim, Ali; Martin, Matthew; Constantinou, Constantinos; Sangthong, Burapat; Brown, Carlos; Kasotakis, George; Demetriades, Demetrios; Belzberg, Howard

doi: 10.1001/archsurg.141.7.655pmid: 16847235

HypothesisThe diagnosis of acute respiratory distress syndrome (ARDS) carries significant additional morbidity and mortality among critically injured patients.DesignRetrospective case-control study using a prospectively maintained ARDS database.SettingSurgical intensive care unit (ICU) in an academic county hospital.PatientsAll trauma patients admitted to the ICU from January 1, 2000, to December 31, 2003, who developed ARDS as defined by (1) acute onset, (2) a partial pressure of arterial oxygen–fraction of inspired oxygen ratio of 200 or less, (3) bilateral pulmonary infiltrates on chest radiographs, and (4) absence of left-sided heart failure. Each patient with ARDS was matched with 2 control patients without ARDS on the basis of sex, age (±5 years), mechanism of injury (blunt or penetrating), Injury Severity Score (±3), and chest Abbreviated Injury Score (±1).Main Outcome MeasuresMortality, hospital charges, hospital and ICU lengths of stay, and complications (defined as pneumonia, deep venous thrombosis, pulmonary embolism, acute renal failure, and disseminated intravascular coagulopathy).ResultsOf 2042 trauma ICU admissions, 216 patients (10.6%) met criteria for ARDS. We identified 432 similarly injured control patients. Compared with controls, trauma patients with ARDS had more complications (43.1% vs 9.5%), longer hospital (32.2 vs 17.9 days) and ICU (22.1 vs 8.4 days) lengths of stay, and higher hospital charges ($267 037 vs $136 680) (P<.01 for all), but mortality was similar (27.8% vs 25.0%, P = .48).ConclusionAlthough ARDS is associated with increased morbidity, hospital and ICU length of stay, and costs, it does not increase overall mortality among critically ill trauma patients.Acute respiratory distress syndrome (ARDS) is a well-known complication of major trauma, occurring in 8% to 82% of selected patient populations.These subgroups include patients with pulmonary contusions,severe trauma (Injury Severity Score, >25),head injury,notable base deficit,notable blood transfusion requirement,and notable orthopedic injuries such as long-bone and pelvic fractures.The presence of ARDS is associated with a significant increase in morbidity, an increased use of hospital resources, and up to a 4.3-fold increase in mortality.The additional mortality effect of ARDS among trauma patients has recently come into question. Findings from studieshave suggested that the mortality may be explained by injury severity alone and not by the presence of ARDS. The overall mortality from ARDS is decreasing, and the mortality from trauma-related ARDS is lower than that associated with ARDS from other causes.However, whether ARDS contributes to the mortality remains controversial, with few studieshaving adequate control mechanisms that address this issue. The objective of this study was to examine the contribution of ARDS on the mortality among trauma patients by comparing the mortality among a similarly injured group of patients without ARDS.METHODSData for this study were obtained from a prospectively maintained database from January 1, 2000, through December 31, 2003, of all admissions to the surgical intensive care unit (ICU) at the Los Angeles County–University of Southern California Medical Center, a level I academic trauma center. This database was established in January 2000 to track the incidence of organ system failures, including ARDS, among all patients admitted to the ICU. Data regarding patient demographics, reason for admission, injury or illness severity, and major operative procedures were recorded at the time of admission. Patient medical records, laboratory data, and imaging results were reviewed daily for predefined evidence of organ system failures. The criteria used to define ARDS were those of the American-European Consensus Conference,which included a partial pressure of arterial oxygen–fraction of inspired oxygen ratio of 200 or less, characteristic bilateral pulmonary infiltrates on chest radiographs, and a pulmonary artery occlusion pressure of 18 mm Hg or lower or no clinical evidence of cardiogenic pulmonary edema. In the absence of pulmonary artery occlusion pressures (missing for 36 patients), the diagnosis of noncardiogenic pulmonary edema was established by the critical care service under the supervision of the critical care attending physician.Only trauma patients who required ICU admission for longer than 24 hours were included in the study. Patients with isolated head trauma were excluded. Data regarding mortality, hospital charges, complications, demographics, Injury Severity Score, Abbreviated Injury Score, and hospital and ICU lengths of stay were obtained from our trauma registry. Complications included pneumonia, deep venous thrombosis, pulmonary embolism, acute renal failure, and disseminated intravascular coagulopathy. For each trauma patient who developed ARDS, 2 control subjects were matched on the basis of the following 5 criteria: sex, age (±5 years), mechanism of injury (blunt or penetrating), Injury Severity Score (±3), and chest Abbreviated Injury Score (±1). When more than 2 controls were identified for a case, 2 were randomly selected from the pool using a random number table.Using Fisher exact test or &khgr;2test, data were tested for equality between the ARDS group and the control group. Paired differences in age, Glasgow Coma Scale score, and Injury Severity Score were tested using Wilcoxon signed rank test. Outcomes (survival and complications) between the 2 groups were compared using conditional logistic analysis, an analytic method for matched studies with more than 1 control. The odds ratio with a 95% confidence interval and the Pvalue for its significance between the 2 groups were derived. Statistical significance was set at P<.05. All statistical analysis was performed using STATA version 7.0 (StataCorp LP, College Station, Tex). This study was approved by the institutional review board, and the need for informed consent was waived because the study involved collection of existing data in such a manner that subjects could not be identified.RESULTSDuring the 4-year study period, there were 2042 trauma-related ICU admissions. Two hundred sixteen patients met criteria for ARDS, for an incidence of 10.6%. The patients with ARDS were then matched with 432 similarly injured controls. Table 1gives the characteristics of the ARDS and control groups. There was no difference for overall mortality between the ARDS group (60/216 [27.8%]) and the control group (108/432 [25.0%]) (odds ratio, 1.11; 95% confidence interval, 0.85-1.45; P = .48) (Table 2).Table 1. Demographic and Admission Characteristics Among Patients With and Without Acute Respiratory Distress Syndrome (ARDS)*CharacteristicARDS Group(n = 216)Control Group(n = 432)PValue†Age, mean ± SD, y42 ± 1941 ± 19.57Age group, y 1-145 (2.3)9 (2.1).85 15-55157 (72.7)322 (74.5).61 >5554 (25.0)101 (23.4).65Male sex169 (78.2)327 (75.7).47Mechanism of injury Blunt157 (72.7)313 (72.5).95 Penetrating59 (27.3)119 (27.5).95Glasgow Coma Scale score,  mean ± SD11 ± 511 ± 5.12Abbreviated Injury Score ≥3‡ Chest80 (37.0)157 (36.3).86 Abdomen67 (31.0)125 (28.9).58 Extremity55 (25.5)124 (28.7).38 External2 (0.9)3 (0.7).75Injury Severity Score,  mean ± SD26 ± 1325 ± 13.49  ≤1547 (21.8)91 (21.1).84  16-2561 (28.2)126 (29.2).81  >25108 (50.0)215 (49.8).96 *Data are given as number (percentage) unless otherwise indicated. †Equality in proportions by Fisher exact test or by &khgr;2test as appropriate. Paired difference in age, Glasgow Coma Scale score, and Injury Severity Score by Wilcoxon signed rank test. ‡The numbers of patients do not sum to the sample totals because of missing data.Table 2. Complications or Death Among Patients With Acute Respiratory Distress Syndrome (ARDS) and Control SubjectsOutcomeNo. (%)Odds Ratio (95% Confidence Interval)*PValueARDS Group(n = 216)Control Group(n = 432)Pneumonia43 (19.9)23 (5.3)3.74 (2.32-7.56)<.01Acute renal failure25 (11.6)8 (1.9)6.25 (2.87-13.60)<.01Disseminated intravascular coagulopathy9 (4.2)9 (2.1)2.00 (0.81-4.97).13Deep venous thrombosis6 (2.8)1 (0.2)12.00 (1.45-99.05)<.01Pulmonary embolism6 (2.8)1 (0.2)12.00 (1.45-99.05)<.01Any complications†93 (43.1)41 (9.5)4.53 (3.26-6.30)<.01Death60 (27.8)108 (25.0)1.11 (0.85-1.45).48 *Derived by conditional logistic analysis. †Some patients had more than 1 complication.Table 2compares specific and overall complications between the 2 groups. There were significantly more overall complications in the ARDS group (43.1%) compared with the control group (9.5%) (odds ratio, 4.53; 95% confidence interval, 3.26-6.30; P<.01). The most common complication in the ARDS group was pneumonia (19.9%), followed by acute renal failure (11.6%).Table 3compares the hospital charges and the hospital and ICU lengths of stay between the 2 groups. The ARDS group had an overall mean ICU length of stay of 22.1 days vs 8.4 days in the control group (P<.01). When only survivors were examined, the mean ICU length of stay was 24.0 days in the ARDS group vs 9.9 days in the control group (P<.01) (Table 4). As expected, the ARDS group had significantly higher hospital charges than the control group ($267 037 vs $136 680, P<.01) (Table 3).Table 3. Hospital Charges and Hospital and Intensive Care Unit (ICU) Lengths of Stay Among Patients With Acute Respiratory Distress Syndrome (ARDS) and Control Subjects*VariableARDS Group(n = 216)Control Group(n = 432)DifferenceHospital charges, $267037 ± 256548†136680 ± 170764‡128668 ± 19363Length of stay, d Hospital32.2 ± 28.2§17.9 ± 19.7&par;13.9 ± 2.1 ICU22.1 ± 21.1¶8.4 ± 10.7#13.5 ± 1.5 *Data are given as mean ± SD. P<.01 for all comparisons (Wilcoxon signed rank test). †Minimum, median, and maximum are $10967, $190405, and $1 921002, respectively. ‡Minimum, median, and maximum are $5207, $85390, and $1 475604, respectively. §Minimum, median, and maximum are 2, 26, and 217 days, respectively. &par;Minimum, median, and maximum are 1, 12, and 212 days, respectively. ¶Minimum, median, and maximum are 1, 17, and 124 days, respectively. #Minimum, median, and maximum are 1, 5, and 118 days, respectively.Table 4. Hospital Charges and Hospital and Intensive Care Unit (ICU) Lengths of Stay Among Survivors*VariableARDS Group(n = 156)Control Group(n = 324)DifferenceHospital charges, $295335 ± 241469†164028 ± 179783‡131307 ± 21837Length of stay, d Hospital36.9 ± 27.1§21.9 ± 20.5&par;14.9 ± 2.4 ICU24.0 ± 19.5¶9.9 ± 11.5#14.1 ± 1.7 Abbreviation: ARDS, acute respiratory distress syndrome. *Data are given as mean ± SD. P<.01 for all comparisons (Wilcoxon signed rank test). †Minimum, median, and maximum are $24328, $239992, and $1 921002, respectively. ‡Minimum, median, and maximum are $10704, $116064, and $1 475604, respectively. §Minimum, median, and maximum are 5, 31, and 217 days, respectively. &par;Minimum, median, and maximum are 2, 17, and 212 days, respectively. ¶Minimum, median, and maximum are 2, 20, and 134 days, respectively. #Minimum, median, and maximum are 1, 6, and 118 days, respectively.COMMENTMajor trauma is a well-known risk factor for the development of ARDS. Its presence is associated with higher morbidity and with higher raw mortality rates.However, attributable mortality from ARDS among trauma patients is not well defined.By matching a group of trauma patients who developed ARDS with an equally injured group of patients who did not develop ARDS, we sought to determine if the presence of ARDS affected for mortality (27.8% in the ARDS group vs 25.0% in the control group, P = .48). In contrast, the ARDS group had notably more complications, longer hospital and ICU lengths of stays, and higher hospital costs.The overall mortality from ARDS has decreased during the past few years.This decrease seems more pronounced in trauma patients, among whom the mortality rates associated with ARDS are consistently lower than those associated with non–trauma-related ARDS.Improved critical care managementand the use of lower tidal volume ventilationin patients with ARDS may explain some of this decline. There also seems to be less endothelial and alveolar epithelial injury in trauma-related ARDS compared with non–trauma-related ARDS,which may also help explain the lower mortality rates seen with trauma-related ARDS.Despite the notable decline in ARDS-related mortality among all populations, its presence is still associated with a significant increase in morbidity and mortality.In a prospective study performed 10 years ago, Hudson et alfound that mortality among trauma patients increased 4.3-fold if they developed ARDS. In another study by Miller et al,trauma patients who developed ARDS experienced 36% mortality compared with 5% mortality if ARDS was not present (P<.001). Similarly, Johnston et alreported 20% mortality among trauma patients with ARDS compared with 12% among trauma patients without ARDS (P<.001). Despite these higher raw mortality rates among trauma patients who develop ARDS, comparisons between the 2 groups may be problematic. Patients who develop ARDS often have higher injury severity, more physiologic disturbances, and increased comorbidities. Some argue that the presence of ARDS is not a complication of trauma but rather is a marker of the severity of trauma.What remains unanswered is whether the higher mortality rates are a result of the ARDS or a result of patient factors such as injury severity and preexisting disease. Unfortunately, there is a scarcity of studies that adequately define the attributable mortality from ARDS among trauma patients.In the only study (to our knowledge) in the literature that attempted to examine the independent contribution of ARDS on mortality among trauma patients, Treggiari et alin a prospective cohort study found that there was no association of mortality with ARDS (relative risk, 1.23; 95% confidence interval, 0.63-2.43) after adjustment for age, Injury Severity Score, and Acute Physiology Score. Our study findings seem to support this in that mortality among similarly injured trauma patients with and without ARDS was similar (27.8% vs 25.0%; odds ratio, 1.11; 95% confidence interval, 0.85-1.45).It is not surprising that complications, hospital and ICU lengths of stay, and hospital costs were significantly higher in the ARDS group compared with the control group. The presence of any complication has been shown to increase the length of stay and costs.Other studieshave documented similar findings and emphasize the overall burden of ARDS on the health care system.CONCLUSIONSTrauma patients who develop ARDS have no increased mortality compared with an equally injured group of patients who did not develop ARDS. However, ARDS was associated with increased complication rates, hospital and ICU lengths of stay, and hospital charges. Because mortality is predicted more from injury severity and not the subsequent development of ARDS, future studies regarding effective treatment of ARDS may need to target outcomes other than mortality among trauma patients.Correspondence:Ali Salim, MD, Los Angeles County–University of Southern California Medical Center, 1200 N State St, Room 9900, Los Angeles, CA 90033 ([email protected]).Accepted for Publication:June 14, 2005.REFERENCESDBHoytRKSimonsRJWinchellA risk analysis of pulmonary complications following major trauma.J Trauma1993355245318411274LDHudsonJAMilbergDAnardiRJMaunderClinical risks for development of the acute respiratory distress syndrome.Am J Respir Crit Care Med19951512933017842182MCHollandRCMackersieDMorabitoThe development of acute lung injury is associated with worse neurologic outcome in patients with severe traumatic brain injury.J Trauma20035510611112855888PNavarrete-NavarroARodriguezNReynoldsAcute respiratory distress syndrome among trauma patients: trends in ICU mortality, risk factors, complications and resource utilization.Intensive Care Med2001271133114011534560MMTreggiariLDHudsonDPMartinNSWeissECaldwellGRubenfeldEffect of acute lung injury and acute respiratory distress syndrome on outcome in critically ill trauma patients.Crit Care Med20043232733114758144PJOffnerALde SouzaEEMooreAvoidance of abdominal compartment syndrome in damage-control laparotomy after trauma.Arch Surg200113667668111387007PRMillerMACroceTKBeeARDS after pulmonary contusion: accurate measurement of contusion volume identifies high-risk patients.J Trauma20015122323011493778PRMillerMACrocePDKilgoJScottTCFabianAcute respiratory distress syndrome in blunt trauma: identification of independent risk factors.Am Surg20026884585012412708JLAtkinsonAcute lung injury in isolated traumatic brain injury.Neurosurgery199741121412269361081EHKincaidPRMillerJWMeredithNRahmanMCChangElevated arterial base deficit in trauma patients: a marker of impaired oxygen utilization.J Am Coll Surg19981873843929783784JWDavisSNParksKLKaupsHEGladenSO’Donnell-NicolAdmission base deficit predicts transfusion requirements and risk of complications.J Trauma1996417697748913202NWinJMontgomeryDSageMStreetJDuncanGLucasRecurrent transfusion-related acute lung injury.Transfusion2001411421142511724989TADavidsonESCaldwellJRCurtisLDHudsonKPSteinbergReduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients.JAMA19992813543609929089PValtaAUusaroSNunesERuokonenJTakalaAcute respiratory distress syndrome: frequency, clinical course, and costs of care.Crit Care Med1999272367237410579250LWEberhardDJMorabitoMAMatthayInitial severity of metabolic acidosis predicts the development of acute lung injury in severely traumatized patients.Crit Care Med20002812513110667511RLDoyleNSzaflarskiGModinJPWiener-KronishMAMatthayIdentification of patients with acute lung injury: predictors of mortality.Am J Respir Crit Care Med1995152181818248520742TRRoccoJrSEReinertWCioffiDHarringtonGBuczkoHHSimmsA 9-year single-institution, retrospective review of death rate and prognostic factors in adult respiratory distress syndrome.Ann Surg200123341442211224631JAMilbergDRDavisKPSteinbergLDHudsonImproved survival of patients with acute respiratory distress syndrome (ARDS): 1983-1993.JAMA19952733063097815658GRBernardAArtigasKLBrighamConsensus Committee. Report of the American-European Consensus Conference on acute respiratory distress syndrome: definitions, mechanisms, relevant outcomes, and clinical trial coordination.J Crit Care1994972818199655DEMcClintockMMatthayWhy does acute lung injury have no impact on mortality in patients with major trauma?Crit Care Med20043258358414758183MDEisnerTThompsonLDHudsonAcute Respiratory Distress Syndrome NetworkEfficacy of low tidal volume ventilation in patients with different clinical risk factors for acute lung injury and the acute respiratory distress syndrome.Am J Respir Crit Care Med200116423123611463593Acute Respiratory Distress Syndrome NetworkVentilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome.N Engl J Med20003421301131810793162MMossMKGillespieLAckersonFAMooreEEMoorePEParsonsEndothelial cell activity varies in patients at risk for the adult respiratory distress syndrome.Crit Care Med199624178217868917025LBWareERConnerMAMatthayvon Willebrand factor antigen is an independent marker of poor outcome in patients with early acute lung injury.Crit Care Med2001292325233111801836MDEisnerPParsonsMAMatthayLWareKGreeneAcute Respiratory Distress Syndrome NetworkPlasma surfactant protein levels and clinical outcomes in patients with acute lung injury.Thorax20035898398814586055CJJohnstonGDRubenfeldLDHudsonEffect of age on the development of ARDS in trauma patients.Chest200312465365912907556EWElyAMBakerGWEvansEFHaponikThe distribution of costs of care in mechanically ventilated patients with chronic obstructive pulmonary disease.Crit Care Med20002840841310708175EEstenssoroADubinELaffaireIncidence, clinical course, and outcome in 217 patients with acute respiratory distress syndrome.Crit Care Med2002302450245612441753ABCooperNDFergusonPJHanlyLong-term follow-up of survivors of acute lung injury: lack of effect of a ventilation strategy to prevent barotrauma.Crit Care Med1999272616262110628599

Macario, Alex; Morris, Dean; Morris, Sharon

doi: 10.1001/archsurg.141.7.659pmid: 16847236

HypothesisA handheld wand-scanning device (1.5 lb, battery powered, 10 × 10 × 1.5 in) has been developed to detect commonly used surgical gauze sponges, which have been tagged with a radiofrequency identification (RFID) chip. We tested the hypothesis that this wand device has a successful detection rate of 100%, with 100% specificity and 100% sensitivity.DesignProspective, blinded, experimental clinical trial.SettingStanford University Medical Center, Stanford, Calif.PatientsEight patients undergoing abdominal or pelvic surgery.InterventionsEight untagged sponges (1 control per patient) and 28 RFID sponges were placed in the patients. Just before closure, the first surgeon placed 1 RFID sponge (adult laparotomy tape; 18 × 18 in, 4-ply) in the surgical site, while the second surgeon looked away so as to be blinded to sponge placement. The edges of the wound were pulled together so that the inside of the cavity was not exposed during the detection experiments. The second (blinded) surgeon used the wand-scanning device to try to detect the RFID sponge.Main Outcome MeasuresA successful detection was defined as detection of an RFID sponge within 1 minute. We also administered a questionnaire to the surgeon and nurse involved in the detections to assess ease of use.ResultsThe RFID wand device detected all sponges correctly, in less than 3 seconds on average. There were no false-positive or false-negative results.ConclusionsWe found a detection accuracy of 100% for the RFID wand device. Despite this engineering success, the possibility of human error and retained sponges remains because handheld scanning can be performed incorrectly.Inadvertently leaving sponges inside patients who undergo surgery continues to occur despite manual counting of sponges by operating room (OR) personnel. A landmark retrospective studyof claims and incident reports of retained sponges or instruments filed with a Massachusetts insurer estimated the incidence as approximately 1 in every 10 000 surgical procedures that involve an open cavity. Two thirds of the reported cases were for surgical sponges. The risk factors for retained foreign bodies were emergencies, with unplanned changes in procedure and patients with higher body mass indexes.Retained sponges may cause no adverse effects in patients and may remain undiscovered for decades.Alternatively, retained sponges may lead to serious sequelae, including sepsis, intestinal obstruction, fistulization, and death.The Agency for Healthcare Research and Quality used patient safety indicators to identify medical injuries in 7.45 million hospital discharge abstracts from 994 acute care hospitals across 28 states in 2000; a discovered foreign body added 4 days to the average hospital stay, with 57 patients dying because of this error in 2000.A better system to prevent retained foreign bodies before the patient leaves the OR would improve patient safety. For example, detecting retained surgical sponges by electronic article surveillance via magnetomechanical technology (often used to prevent theft in retail stores) may help solve this problem.For the first time, a handheld wand-scanning device (1.5 lb, battery powered, 10 × 10 × 1.5 in) has been developed (ClearCount Medical Solutions Inc, Pittsburgh, Pa) to detect commonly used gauze sponges, which have been tagged with a radiofrequency identification (RFID) chip (Sokymat, SA, Granges, Switzerland). The RFID tags are tiny microchips that act as transponders, listening for a radio signal sent by transceivers or RFID scanners.Continuing reduction in RFID tag costs and improving performance now make it economically feasible to tag surgical supplies.The goal of this feasibility study was to determine the success rate of the wand device in correctly detecting RFID-tagged surgical sponges placed in the surgical sites of 8 patients. We tested the hypothesis that the wand device would produce a successful detection rate of 100%, with 100% specificity and 100% sensitivity. A successful detection was defined as detection of an RFID sponge within 1 minute of beginning the scan. We also administered a 1-page written questionnaire to the surgeon and nurse involved in the detections to assess perceived ease of use of the RFID wand device.METHODSAfter approval from Stanford University's Human Subject Panel, 8 patients were enrolled after written informed consent was obtained. This convenience sample of 8 patients underwent a variety of elective abdominal and pelvic procedures while under general anesthesia. An RFID tag that measured 20 mm in diameter and 2 mm in width was sewn securely into each sponge and sterilized in the usual manner with the ethylene oxide technique.Once the surgical procedure was finished and just before closure of the incision, the first surgeon (either the randomly selected resident or the attending surgeon) placed 1 RFID surgical sponge (adult laparotomy tape; 18 × 18 in, 4-ply) in the surgical site while the second surgeon looked away so as to be blinded to sponge placement. The second surgeon remained blinded for all the sponge placements in each patient.A computer-generated random-number table (http://www.random.org/nform.html) was used to randomly select 1 of the 4 quadrants in the abdomen for the location of sponge placement. No suture material was used to close the wound until the detection experiments were finished. The edges of the wound were pulled together so that the inside of the cavity was not exposed during the detection experiments. After sponge placement, the second (blinded) surgeon used the handheld wand device to try to detect the RFID sponge. The scan technique was standardized, following the sequence of right upper quadrant, right lower quadrant, left lower quadrant, left upper quadrant, and then midline.We recorded the time from the wand device (enclosed in a sterile, plastic, disposable sheath) being given to the surgeon until detection. Three other random placements of sponges were performed in each patient. For each patient, one of these detection experiments was with an untagged sponge (as a control) to determine the false-positive rate (the device indicating the presence of an RFID sponge when there was none). We also computed the false-negative rate, defined as the device not indicating the presence of an RFID sponge when one had been placed. In 5 of the patients (determined by random-number generator), we placed 2 RFID sponges simultaneously to determine if the wand device would detect a concurrent second RFID sponge.After completion of the detection experiment, we administered a 1-page survey to the surgeon and nurse who had used the RFID wand device. Questions related to the wand device's overall quality, its ease of use, and its ability to contribute to efficiency and patient safety, and responses were based on a 0 to 100 visual analog scale. We also asked what would be a reasonable price for the hospital to pay to have the RFID wand device available to all its surgical patients. This was done to try to assign a monetary amount to the perceived value of the device. We left space open at the bottom of the survey for free text, asking for suggestions to improve the device and for general comments.RESULTSCharacteristics of the 8 patients enrolled are given in Table 1. Eight untagged sponges (1 per patient) and 28 RFID-tagged sponges were placed in the 8 patients. The RFID wand device detected all sponges correctly. There were no false-positive or false-negative results. The RFID sponges were detected by the surgeon using the wand in less than 3 seconds on average (Table 2). Both surgeons and nurses rated the RFID wand device high for ease of use and its ability to improve patient safety and lowest for its ability to increase efficiency (Table 3). Feedback obtained via written comments described the users' preference for a smaller wand device (Table 4). Concern was also expressed that human error would persist in the detection of RFID sponges unless the technology was designed to be failsafe.Table 1. Characteristics in 8 PatientsCharacteristicFindingHeight, mean (SD), cm173.4 (10.1)Weight, mean (SD), kg76.0 (13.6)Age, mean (SD), y48.8 (18.1)Female, %50 Case duration, mean (SD), min254.0 (100.5)Surgical procedures, No. Removal of pancreatic or ampulla mass2  Removal of pelvic mass1  Total abdominal hysterectomy1  Kidney transplantation2  Colon resection1  Radical prostatectomy1 Table 2. Time to Detect Gauze Sponges Placed in the Surgical SiteSponge TypeNo. of Sponges Placed (No. of Patients)Time, Mean (SD), sTime, Median (Range), sControl8 (8)14.5* (13.4)12.0 (2.0-45.0)Single18 (8)2.7 (1.8)2.0 (1.0-7.0)Double10 (5)2.6 (1.7)3.0 (1.0-5.0) *Time for surgeon to indicate that there were no radiofrequency identification sponges in the site.Table 3. Results of Questionnaire SurveyQuestionVisual Analog Scale Score, Mean (SD)*SurgeonCirculator NurseHow would you rate the overall quality of this wand device?81 (12)74 (21)How easy do you think this wand device was for you to use?85 (9)93 (6)How well do you think this device contributes to your efficiency (ie, ability to do more in less time)?66 (23)73 (21)How well do you think this wand device adds to patient safety (ie, avoids complications)?78 (30)94 (3)What is a reasonable price for such a product per patient?$144 ($158)$88 ($107)Who should do the scan once commercially available?  Surgeon, %7550  Scrub technician, %2525  Surgeon and scrub technician, %025 *On a scale of 0 to 100. Data are presented as visual analog scale scores unless otherwise indicated.Table 4. Analysis of Comments by Surgeon or Nurse User*Comment Made by UserNo. of Times Comment MadePrefer smaller scan device9Training on use of device is needed; human error persists if scan not done correctly or if done too early4Sterile sheath needs to be transparent and less cumbersome3Desire to determine sponge location (eg, localize to upper quadrant vs lower quadrant)2Prefer disposable, single-use wand2Next-generation wand should have start/stop button; otherwise, machine detects sponges outside field (eg, sponges on table)2Need to have RFID sponge visually different from normal sponge; otherwise, the 2 may be confused2The RFID tag needs to be securely sewn into gauze sponge1Ease of use improved if surgical field is cleared of instruments1Signal of positive sponge detection needs to be distinct (eg, either voice, red/green light, or beep)1 Abbreviation: RFID, radiofrequency identification. *Some respondents made more than 1 comment.COMMENTRetained sponges may be referred to as either a textiloma(from the Latin term textileand oma, meaning “swelling”)or a gossypiboma(from the Latin Gossypium, the genus of cotton plants, and borna, a Kiswahili term meaning “place of concealment”).The inflammatory reaction to the nonabsorbable cotton sponge leads to a variety of costs to society, including pain and emotional distress experienced by the patient, imaging studies to diagnose the problem, a subsequent hospitalization for reoperation, and litigation expenses and patient compensation for perceived negligence of the facility and staff.The currently recommended OR nursing procedure requires 3 separate counts of potential foreign bodies: once before the surgery, then again during the surgery, and finally once the incision is closed.However, use of this preventive measure is not universal. In fact, a retrospective reviewpublished in 1996 of malpractice claims related to retained sponges or surgical materials found that sponge counts had been false in 76% of nonvaginal surgical procedures, with an average indemnity payment of $51 808.Most surgical facilities do not routinely perform postoperative radiographic imaging to find instruments or the radiopaque marker in most sponges to confirm that sponge and needle counts are correct. In the event of a miscount (ie, a discrepancy in numbers such that counts are off), an intraoperative x-ray film of the involved body cavity is obtained. Despite these advances, most retained sponges occur with normal counts, perhaps falling outside the human safeguards designed to prevent these types of errors.Although bar coding requires direct visualization of the item for identification and may be useful for identifying and counting an inventory of items in the OR, the RFID system operates by proximity and can read through tissue. The RFID system is composed of 2 basic components: a reader and a plurality of transponders, or tags, which are applied to the items to be tracked. The RFID tags have an antenna for receiving and sending signals to and from the reader and an encapsulation that protects the circuit and antenna from the external environment. The RFID tag also has an integrated circuit that contains specific item-level data (eg, what the item is, its inventory number, and the date of manufacture). This is unlike the larger (45 × 10-mm) electronic article surveillance tag used to prevent theft in stores, which cannot contain or relay such data.It is unknown whether RFID technology can be used as a failsafe tool for reducing the incidence of retained foreign bodies. The RFID system we studied exhibited no electronic interference from OR equipment such as the anesthesia machine.When an RFID chip sewn into the sponge receives a certain radio query, the sponge responds with a unique identification code back to the scanner. The RFID tags are powered by the radio signal from the scanner. These broadcast signals are designed to be read between a few inches and several feet away, depending on the size of the tags and the size and power of the scanner antenna. As an added safety precaution, the RFID tags were checked to be in working condition before our experiments. The RFID tags used in this study have a failure rate due to malfunctioning of less than 3 per million.In the 8 patients we studied who underwent a variety of surgical procedures, 8 untagged control sponges (1 per patient) and 28 RFID-tagged sponges were placed. We found a detection accuracy for the RFID wand device of 100%, with a 0% false-positive rate and a 0% false-negative rate. Despite this engineering success, the clinical trial raised important user issues, such as the risk of human error and retained foreign bodies. For example, if the scan is performed incorrectly (eg, the wand scan is performed farther away than a few inches from the skin or the device does not cover the entire surface area of the surgical site), retained sponges can be missed. Retained sponges could also be missed, even if the technical detection works accurately, if the scan were performed too early, such as if an additional sponge were placed in the wound to help with closure after the final RFID scan had been performed.Ideally, the sponge scan system would pinpoint the exact location of the sponge so that if the sponge needed to be retrieved, it would be easier to find without disrupting the surgical repair. Certainly, an economic analysis of such a sponge detection technology is necessary to justify the additional acquisition costs of an RFID system and tagged sponges for use in the OR. Surgeons who used the device suggested a wide range of reasonable prices for acquisition of such a product, with the average being approximately $144 per patient.The cost to manufacture the RFID wand device once commercialized is unknown. Comparison of the potential benefits of RFID technology to the price hospitals pay to acquire it will have to factor in the number of ORs in which the sponge-tracking technology is deployed, the baseline incidence of a retained foreign body (Does the facility perform a lot of high-risk cases, such as major abdominal cancer surgery, or low-risk cases, such as breast biopsies?), the amount of counting time nurses can save with tagged sponges, and liability costs.The long-term objective may be to have sponge tracking as part of an overall OR supply-tracking system, including metal surgical instruments. Ultimately, for any device or drug, the gold standard for showing effectiveness is a randomized clinical trial. However, such a study on whether RFID sponges can reduce the incidence of retained foreign bodies would require thousands of patients. For example, if we assumed a retained sponge incidence of 1 per 5000 population and the aim was to determine if RFID sponge use halves this incidence to 1 per 10 000 population, then more than 50 000 patients would need to be enrolled in each of the 2 groups.The true scope of retained foreign bodies after surgery may be underreported in the medical literature, perhaps because of medical privacy and legal concerns.Since 2003, Minnesota hospitals are required by law to report 27 categories of preventable accidents, as defined by the National Quality Forum, known as “never events” (eg, amputating the wrong limb or sending a newborn home with the wrong family).More than half of the 99 reported mistakes occurred during surgery. Of those, 31 involved retained foreign objects. Hospitals had between 0 and 6 retained sponge or instrument incidents during the 15-month reporting period. On the basis of such available published data, a typical hospital annually performing 10 000 open body cavity operative procedures can expect 1 to 2 retained foreign-body cases per year.The surgical team will remain responsible for inspecting the surgical site and avoiding retained foreign bodies. Technologies to increase safety in the OR, such as the RFID wand device described in this article, deserve further study to assess if they should be added to manual counting (rather than replace it). However, related human and system factors need to be addressed as well because it is likely that technology alone will not be foolproof in solving the retained foreign-body problem.Correspondence:Alex Macario, MD, MBA, Department of Anesthesia, H3580, Stanford University School of Medicine, 300 Pasteur Dr, Stanford, CA 94305-5640 ([email protected]).Accepted for Publication:June 14, 2005.Financial Disclosure:Dean and Sharon Morris own several patents and have patents pending related to RFID- tagged sponges. Dean Morris is a director and Sharon Morris is a nursing consultant for ClearCount Medical Solutions Inc.Funding/Support:This study was supported in part by grant 1R43 NR07915-01A2 from the Small Business Innovation Research Program and the National Institutes of Health.Acknowledgment:We thank Steve Fleck, MBA, and Gautam Gandhi, MBA, at ClearCount Medical Solutions Inc for providing the RFID wand device and sponges. We also thank James D. 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Stamou, Konstantinos M.; Toutouzas, Konstantinos G.; Kekis, Panagiotis B.; Nakos, Socrates; Gafou, Anthippi; Manouras, Andreas; Krespis, Eustathios; Katsaragakis, Stylianos; Bramis, John

doi: 10.1001/archsurg.141.7.663pmid: 16847237