fk506, unlike cyclosporine, does not adversely affect blood flow or absorption in small intestine...

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April 1995 SSAT A1247 EXPERIMENTAL RESULTS WITH A PARTIALLY ABSORBABLE IMPLANT TO PREVENT GASTROESOPHAGEAL REFLUX H.J. Stein, H. Feussner, J. Holste, S. J. M. Kraemer, J.R. Siewert Department of Surgery, Klinikum rechts der Isar, Miinchen, Germany The long term functional results of fundoplication in patients with gastroesophageal reflux disease are largely dependent on the experience of the surgeon. We established an experimental model of gastro- esophageal reflux and evaluated the anti-reflux efficacy of a partially absorbable implant around the gastroesophageal (GE) junction, which can easily be applied laparoscopically or via laparotumy. Material and Methqdsl. Experiments were performed in a total of 20 miniature pigs. Twelve animals had a circular resection of the musculature at the GE-junction to induce gastroesophageal reflux. In 8 of these myectomized animals and an additional 8 animals with an intact musculature at the GE-junction an anti-reflux implant (Ethicon, Germany) consisting of 80% Vicryl, 10% PDS, and 10% Prolene was placed around the GE-junction in a loose fashion. Manometry was performed after myectomy and after placement of the implant. Prolonged esophageal pH monitoring and endoscopy were performed every 3 months. The animals were sacrificed after 6 to 12 months. Results: Circular myectomy resulted in a significant reduction of the lower esophageal sphincter pressure (p<0.001), acid reflux into the esophagus on pH monitoring (p<0.001), and gross esopbagitis. The implant around the GE-junction increased the resting pressure of the lower esophageal sphincter (p<0.01) and completely suppressed acid reflux on pH monitoring and endoscopy for up to 12 months (p<0.01). On autopsy the absorbable component of the implant had completely disappeared after 6 months. The remaining non-absorbable components were overgrown by connective tissue and formed a loose ring around the GE-junction which allowed free movement of the distal esophagus. Conclusion: In the experimental situation, gastroesophageal reflux can be completely suppressed by an easily applicable and partially absorbable implant placed around the GE-junction. A clinical assessment of the implant in patients with gastroesophageal reflux disease appears warranted. e THE FAILED ANTI-REFLUX PROCEDURE: CAUSES OF FAILURE AND MANAGEMENT STRATEGIES H. J. Stein, H. Feussner. J. R. Siewert. Deparmaent of Surgery, Klinikum rechts der Isar, M~inchen, Germany. With the advent of laparoscopic surgery the number of anti-reflux procedures performed has virtually exploded at some centers. Failed anti-reflux procedures are therefore likely to becomea more commonproblem in the near furore. We report our experience with a consecutiveseries of patients with a failed anti-reflux procedure. Material and Methods: Between 1984 and 1994, 89 patients were seen because of recurrent, persistent or new symptoms after a previous Nissen fundoplication (N = 56), semi-fundoplication(N = 14), Angelchikprosthesis (N = 10), or gastropexy (N=9). All patients had a detailed symptomatic assessment, endoscopy, contrast rnemgenography,esophageal manometryand esophageal pH monitoring to identify the cause of failure. A revisional procedure was performed in 59 patients. Median follow up is 42 mouths. Results: Recurrent or persisting heartburn or regurgitation alone were the most common primary symptoms(46%) followed by dysphagia(34%) and a combination of dysphagia and heartburn (t5%). Gas bloat or gastric denervationsymptomswere rare reasons for referral (5%). Detailed assessment identified a partial or complete disruption of the anti-reflux procedure with recurrent reflux (42/89), a displaced repair (20/8% a too tight or long fundoplication (10/89) or an underlying primary motor disorder (8/89) as the most common reason for failure of the primary procedure, Vagal damage(4/89) and herniation of the stomach or the repair into the chest (5/89) were less common, Disruption of the anti-reflux procedure was frequently related to the use of non-absorbaNe suture material, displacementof the repair was commonly observed in patients who had a highly selective vagotomyin combination with the initial anti-refluxprocedure, and dysphagiadue to an underlying motor disorder usually resulted from inadequate patient selection, Herniation of the repair was only seen in patients who did not have a closure of the hiatus, Recurrent reflux symptoms alone could easily be treated by proton pump inhibitors (t7 patients) or re-fimdoplication(25 patients). In contrast, dysphagiadue to a displaced wrap, a too long or too tight wrap, an underlyingmotor disorder, or herniation could only be resolved by revisional surgery which always included an undoing of the previous repair (34 patients) and a tailored redo anti-reflux procedure only in those xvith objectivelydocumentedreflux. With this approachgood to excellent results could be achieved in 78/89 (87.6%) patients Conclusions: Technical factors and wrong patient selection are the most common reasons for failure of anti-reflux surgery. The successful management of these patients requires an individual therapeutic approachbased on an exact analysis of the reasons responsible for failure of the initial procedure. Q INCISIONAL HERNIAt GREATER RISK WITH MORBIDLY OBESE THAN STEROID DEPENDANT PATIENTS; LOW RECURRENCE RATE WITH PREFASCIAL POLYPROPYLENE MESH REPAIR H.J. Sugerman, J.M. Kellum, H.D. Reine~ E~J. DeMaria, H.H. Newsome, J.W. Lowry Medical College of Virginia, Richmond, Virginia Incisional hernia incidence and repair tech- nique were evaluated in patients who underwent a gastric bypass (GBP) for morbid obesity vs a colectomy/ileoanal procedure for ulcerative colitis. Methods: The fascia was closed in both groups with running #2 polyglycolic acid suture. All were midline incisions, from xiphoid to umbilicus in the obese and mid-epigastrium to pubis in the colitis groups. 98 patients (7i women, 27 men; 45 ± i years old) underwent hernia repair by one surgeon (HJS) with prefascial polypropylene mesh from 11/83 to 11/94. Of these, 80 had undergone GBP, 46 had 1 and 17 had 2 to 9 previous repairs, 6 with a prior mesh pre- peritoneal technique. Results, Hernia Incidence: Incisional hernia occurred in 16.9% (152/899) of GBP patients without vs 41% (3i/75) with a previous hernia (p < 0.001) vs 3.5% (6/171) of the colitis group (p < 0.001), of whom 102 were taking prednisone (32 ± 2 mg/day), 3 were morbidly obese (BMI ~ 35 kg/m 2) and 2 of these were not taking prednisone. Results, Hernia Repair: 1 patient was lost to follow-up. Mean follow-up was 20 ± 2 mos (range 1 to 98 mos) . Complications were seen in 35% of patients and included minor wound infection (12%), major wound infection (5%), seroma (5%), hematoma (3%), chronic pain (6%) and recurrent hernia (4%). Con____c!usions: Severe obesity is a significantly greater risk factor for incisional hernia and hernia recurrence than chronic steroid use in non-obese colitis patients. Other studies have suggested that this is secondary to an increased intra-abdominal pressure (chronic abdominal compartment syndrome). A prefascial polypropylene mesh repair is the optimal method to minimize recurrence in these challenging patients. FK506, UNLIKE CYCLOSPORINE, DOES NOT ADVERSELY AFFECT BLOOD FLOW OR ABBORPTION IN SMALL INTESTINE TRANSPLANTS 8 Sun, K Raqhavendran. S Katz, R Schechner, B Lsvine, V Tsllis, S Greenstein. Dept° of Surgery, Montefiore Medical Centern Bronx, NY We have shown that short-term cyclosporine (CsA) administration causes significant hemo- dynamic and functional disturbances in small intestine transplants (SITx). FK-506 has been reported to have similar side effects to csA on renal graft vasculaturs and has been used clinically in SITX. In this study, we assessed the effects of FKS06 on intestinal graft blood flow (BF} and intramural distribution, vascular resistance (VR), and absorptive function. Three groups Of Lewis rats received isogeneic SITx: Group I--no treatment for i wk (surgical con- trols); Group II--polyethylene glycol (0.6 ml/kg/d, im) for I wk (vehicle controls); Group III--FKS06 (2 mg/kg/d, im) for 1 wk. Graft absorption was determined using maltose absorp- tion test. Intestinal BF and its mucosal and serosal/muscularis distributions were determined using radioactive microsphere technique. Perfusion pressure was measured at the time of microsphere injection to determine VII. Results: Grou~ I (n=7~ II |no8) ~II (no8) Blood Flow(mlJgm/min) Muoosal 1.7±0.4 1.8~0.3 1.7±0.3 Sero/Muso 0.9~0.2 0.9~0.1 1.0~0.2 VasGular Resistance (U/qm) Mucosal 49~12 47~8 48~8 Sero/Muso 94~18 97±16 87~20 Naltose i%bsorption (qlucose mg/dl) 30 Min 205~53 213±25 209~33 60 Nin 227~40 219!27 229±33 No significant differences were found using ANOVA among the three groups for VR, BF, or maltose absorption. We conclude that FKS06 is preferable to CS~ in SITx in terms of preserving graft hemodynamlcs and function.

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Page 1: FK506, unlike cyclosporine, does not adversely affect blood flow or absorption in small intestine transplants

April 1995 SSAT A1247

EXPERIMENTAL RESULTS W I T H A PARTIALLY ABSORBABLE IMPLANT TO PREVENT GASTROESOPHAGEAL REFLUX H.J. Stein, H. Feussner, J. Holste, S. J. M. Kraemer, J.R. Siewert Department of Surgery, Klinikum rechts der Isar, Miinchen, Germany

The long term functional results of fundoplication in patients with gastroesophageal reflux disease are largely dependent on the experience of the surgeon. We established an experimental model of gastro- esophageal reflux and evaluated the anti-reflux efficacy of a partially absorbable implant around the gastroesophageal (GE) junction, which can easily be applied laparoscopically or via laparotumy. Material and Methqdsl. Experiments were performed in a total of 20 miniature pigs. Twelve animals had a circular resection of the musculature at the GE-junction to induce gastroesophageal reflux. In 8 of these myectomized animals and an additional 8 animals with an intact musculature at the GE-junction an anti-reflux implant (Ethicon, Germany) consisting of 80% Vicryl, 10% PDS, and 10% Prolene was placed around the GE-junction in a loose fashion. Manometry was performed after myectomy and after placement of the implant. Prolonged esophageal pH monitoring and endoscopy were performed every 3 months. The animals were sacrificed after 6 to 12 months. Results: Circular myectomy resulted in a significant reduction of the lower esophageal sphincter pressure (p<0.001) , acid reflux into the esophagus on pH monitoring (p<0.001) , and gross esopbagitis. The implant around the GE-junction increased the resting pressure of the lower esophageal sphincter (p<0 .01) and completely suppressed acid reflux on pH monitoring and endoscopy for up to 12 months (p<0.01). On autopsy the absorbable component of the implant had completely disappeared after 6 months. The remaining non-absorbable components were overgrown by connective tissue and formed a loose ring around the GE-junction which allowed free movement of the distal esophagus. Conclusion: In the experimental situation, gastroesophageal reflux can be completely suppressed by an easily applicable and partially absorbable implant placed around the GE-junction. A clinical assessment of the implant in patients with gastroesophageal reflux disease appears warranted.

e THE FAILED ANTI-REFLUX PROCEDURE: CAUSES OF FAILURE AND MANAGEMENT STRATEGIES H. J. Stein, H. Feussner. J. R. Siewert. Deparmaent of Surgery, Klinikum rechts der Isar, M~inchen, Germany.

With the advent of laparoscopic surgery the number of anti-reflux procedures performed has virtually exploded at some centers. Failed anti-reflux procedures are therefore likely to become a more common problem in the near furore. We report our experience with a consecutive series of patients with a failed anti-reflux procedure. Material and Methods: Between 1984 and 1994, 89 patients were seen because of recurrent, persistent or new symptoms after a previous Nissen fundoplication (N = 56), semi-fundoplication (N = 14), Angelchik prosthesis (N = 10), or gastropexy (N=9). All patients had a detailed symptomatic assessment, endoscopy, contrast rnemgenography, esophageal manometry and esophageal pH monitoring to identify the cause of failure. A revisional procedure was performed in 59 patients. Median follow up is 42 mouths. Results: Recurrent or persisting heartburn or regurgitation alone were the most common primary symptoms (46%) followed by dysphagia (34%) and a combination of dysphagia and heartburn (t5%). Gas bloat or gastric denervation symptoms were rare reasons for referral (5%). Detailed assessment identified a partial or complete disruption of the anti-reflux procedure with recurrent reflux (42/89), a displaced repair (20/8% a too tight or long fundoplication (10/89) or an underlying primary motor disorder (8/89) as the most common reason for failure of the primary procedure, Vagal damage (4/89) and herniation of the stomach or the repair into the chest (5/89) were less common, Disruption of the anti-reflux procedure was frequently related to the use of non-absorbaNe suture material, displacement of the repair was commonly observed in patients who had a highly selective vagotomy in combination with the initial anti-reflux procedure, and dysphagia due to an underlying motor disorder usually resulted from inadequate patient selection, Herniation of the repair was only seen in patients who did not have a closure of the hiatus, Recurrent reflux symptoms alone could easily be treated by proton pump inhibitors (t7 patients) or re-fimdoplication (25 patients). In contrast, dysphagia due to a displaced wrap, a too long or too tight wrap, an underlying motor disorder, or herniation could only be resolved by revisional surgery which always included an undoing of the previous repair (34 patients) and a tailored redo anti-reflux procedure only in those xvith objectively documented reflux. With this approach good to excellent results could be achieved in 78/89 (87.6%) patients Conclusions: Technical factors and wrong patient selection are the most common reasons for failure of anti-reflux surgery. The successful management of these patients requires an individual therapeutic approach based on an exact analysis of the reasons responsible for failure of the initial procedure.

Q INCISIONAL HERNIAt GREATER RISK WITH MORBIDLY OBESE THAN STEROID DEPENDANT PATIENTS; LOW RECURRENCE RATE WITH PREFASCIAL POLYPROPYLENE MESH REPAIR H.J. Sugerman, J.M. Kellum, H.D. Reine~ E~J. DeMaria, H.H. Newsome, J.W. Lowry Medical College of Virginia, Richmond, Virginia

Incisional hernia incidence and repair tech- nique were evaluated in patients who underwent a gastric bypass (GBP) for morbid obesity vs a colectomy/ileoanal procedure for ulcerative colitis. Methods: The fascia was closed in both groups with running #2 polyglycolic acid suture. All were midline incisions, from xiphoid to umbilicus in the obese and mid-epigastrium to pubis in the colitis groups. 98 patients (7i women, 27 men; 45 ± i years old) underwent hernia repair by one surgeon (HJS) with prefascial polypropylene mesh from 11/83 to 11/94. Of these, 80 had undergone GBP, 46 had 1 and 17 had 2 to 9 previous repairs, 6 with a prior mesh pre- peritoneal technique. Results, Hernia Incidence: Incisional hernia occurred in 16.9% (152/899) of GBP patients without vs 41% (3i/75) with a previous hernia (p < 0.001) vs 3.5% (6/171) of the colitis group (p < 0.001), of whom 102 were taking prednisone (32 ± 2 mg/day), 3 were morbidly obese (BMI ~ 35 kg/m 2) and 2 of these were not taking prednisone. Results, Hernia Repair: 1 patient was lost to follow-up. Mean follow-up was 20 ± 2 mos (range 1 to 98 mos) . Complications were seen in 35% of patients and included minor wound infection (12%), major wound infection (5%), seroma (5%), hematoma (3%), chronic pain (6%) and recurrent hernia (4%). Con____c!usions: Severe obesity is a significantly greater risk factor for incisional hernia and hernia recurrence than chronic steroid use in non-obese colitis patients. Other studies have suggested that this is secondary to an increased intra-abdominal pressure (chronic abdominal compartment syndrome). A prefascial polypropylene mesh repair is the optimal method to minimize recurrence in these challenging patients.

FK506, UNLIKE CYCLOSPORINE, DOES NOT ADVERSELY AFFECT BLOOD FLOW OR ABBORPTION IN SMALL INTESTINE TRANSPLANTS 8 Sun, K Raqhavendran. S Katz, R Schechner, B Lsvine, V Tsllis, S Greenstein. Dept° of Surgery, Montefiore Medical Centern Bronx, NY

We have shown that short-term cyclosporine (CsA) administration causes significant hemo- dynamic and functional disturbances in small intestine transplants (SITx). FK-506 has been reported to have similar side effects to csA on renal graft vasculaturs and has been used clinically in SITX. In this study, we assessed the effects of FKS06 on intestinal graft blood flow (BF} and intramural distribution, vascular resistance (VR), and absorptive function. Three groups Of Lewis rats received isogeneic SITx: Group I--no treatment for i wk (surgical con- trols); Group II--polyethylene glycol (0.6 ml/kg/d, im) for I wk (vehicle controls); Group III--FKS06 (2 mg/kg/d, im) for 1 wk. Graft absorption was determined using maltose absorp- tion test. Intestinal BF and its mucosal and serosal/muscularis distributions were determined using radioactive microsphere technique. Perfusion pressure was measured at the time of microsphere injection to determine VII. Results: Grou~ I (n=7~ II |no8) ~II (no8) B l o o d Flow(mlJgm/min) Muoosal 1.7±0.4 1.8~0.3 1.7±0.3 Sero/Muso 0 .9~0 .2 0 . 9 ~ 0 . 1 1 . 0 ~ 0 . 2

VasGular Resistance (U/qm) Mucosal 49~12 47~8 48~8 Sero/Muso 94~18 97±16 87~20

Naltose i%bsorption (qlucose mg/dl) 30 Min 205~53 213±25 209~33 60 Nin 227~40 219!27 229±33

No significant differences were found using ANOVA among the three groups for VR, BF, or maltose absorption. We conclude that FKS06 is preferable to CS~ in SITx in terms of preserving graft hemodynamlcs and function.