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The Safety Profile of Wireless Motility Capsule in Patients with Suspected Multiregional Gastrointestinal Dysmotility
Table 2: Percentage of individual prokinetic medications over the 5 year period
AGA Abstracts
upper endoscopy findings were determined. Data were analyzed using chi-square and p < 0.05 was considered significant. Results: 98 patients with GP were identified (10 males and 88 females, age range 19-81 yrs). 20% of the GP subjects (n=20) had 3 cpm GMA, the functional obstructive GP subtype. These 20 GP patients were 18 women and 2 men, average age 41. 80% of the patients (n=78) had gastric dysrhythmias (39 tachygastria, 12 bradygastria and 27 mixed dysrhythmias). These patients were 71 women and 7 men, average age 50. Meal retention at 2 hr and 4 hr averaged 71% and 31% in the normal 3 cpm group and 65% and 32% in the gastric dysrhythmia group. Ingested water volume averaged 509 mL in the normal 3 cpm group and 522 mL in the dysrhythmia group. GP patients with normal 3 cpm rhythm were less likely to have DM (15% v. 41%, p = 0.03), hypothyroidism (5% v. 27%, p=0.04), elevated BMI (25% v. 69%, p < 0.001) and more likely to have endoscopic findings suggestive of pyloric dysfunction, (pylorospasm, tight pylorus or difficulty traversing the pylorus) (55% v 9%, p < 0.001). Patients with GP and normal 3 cpm GMA more frequently received dicyclomine (47% v. 24%, p = 0.047). The majority of patients in both groups had undergone cholecystectomy (63% v 55%, p = 0.52). Similar numbers of patients in each group had depression, anxiety, fibromyalgia or migraine headaches, smoking history and active narcotics or proton pump inhibitors use. Conclusions: 1. Patients with functional obstructive GP with 3 cpm subtype are younger, have significantly lower BMI and are less likely to have diabetes mellitus or hypothyroidism compared with patients with GP and gastric dysrhythmias; 2. Pyloric findings were noted in half of the patients with 3 cpm GMA, and also supports the diagnosis of functional obstructive GP with 3 cpm GMA ; and 3. 20% of patients with GP had normal 3 cpm GMA, suggesting functional gastric outlet obstruction is relatively common and should be considered in evaluating patients with GP.
Su1562 THE SAFETY PROFILE OF WIRELESS MOTILITY CAPSULE IN PATIENTS WITH SUSPECTED MULTIREGIONAL GASTROINTESTINAL DYSMOTILITY Gengqing Song, Cynthia Funk, Jan Santisi, Jack Semler, Michael S. Cline
Su1561 CONCOMITANT USE OF PROKINETIC MEDICATIONS AFTER GASTRIC ELECTRICAL STIMULATION IN PATIENTS WITH MEDICALLY REFRACTORY GASTROPARESIS OVER A 5-YEAR PERIOD Anam Hameed, Shamim Ejaz, Gladis A. Shuttlesworth, John R. Stroehlein, Mehnaz Shafi
BACKGROUND: Wireless motility capsule (WMC) provides a full gastrointestinal (GI) tract transit profile in patients with GI dysmotility and may be able to detect and diagnose multiregional dysmotility. However, there is limited published data available to assess the safety profile of WMC. AIMS: To investigate the safety profile of WMC in patients with upper and lower GI symptoms suggestive of multiregional GI dysmotility. METHODS: Retrospective chart review of 700 patients who presented with nausea, vomiting, early satiety, and / or constipation and had undergone WMC testing for suspected multiregional GI dysmotility from January 2009 to November 2016 at Cleveland Clinic was performed. After an overnight fast, subjects ingested a nutrient bar (260 kcal) followed by the WMC capsule, and wore the data receiver for 5 days. The patients discontinued all laxatives and drugs (including narcotics) that affect motility for 48 hours and PPI for 7 days before the study. Capsule retention was defined as capsule retention in the GI tract for more than 5 days. RESULTS: 1). An analysis of 700 WMC tests revealed 14 reports (8 females, mean age 54 with a standard deviation of 15) of prolonged capsule retention greater than 5 days (11 in the stomach and 3 in the small intestine), corresponding to a prolonged retention rate of 2%. In addition, 1 incidence of equipment or software malfunction prevented the acquisition of interpretable transit data from the WMC. 2). In 14 capsule retentions, all patients had gastroparesis, including 6 diabetic, 5 idiopathic, and 3 postsurgical. 3). In 11 of 14 cases spontaneous passage of the capsule was confirmed via sequential radiograph imaging. 4). Two of the remaining cases had capsules retained in the stomach and required upper endoscopy (EGD) for extraction. In 1 case, a patient had chronic abdominal pain and complained of worsening pain. In the second case, pyloric stenosis was identified and endoscopic pyloroplasty was performed after the WMC test. 5). The remaining prolonged retention underwent partial resection of the small bowel due to small bowel intussusception which was not identified on prior testing including small bowel follow through, computerized tomography and EGD. CONCLUSIONS: 1) WMC is a safe procedure. 2). A capsule retained in the stomach may necessitate EGD and may be monitored by sequential radiograph imaging. 3) Capsule retention in the stomach or small bowel that does not spontaneously resolve may signify an anatomic cause requiring further intervention.
Introduction: Gastric Electrical Stimulation (GES) is an FDA approved therapy for upper gastrointestinal (GI) symptoms in patients with medically refractory gastroparesis. Patients are invariably on prokinetic medications prior to GES. It is unclear how many patients no longer require prokinetic medications after GES implantation. Aim: To assess the continued, long term use of prokinetic medications after placement of the GES device in gastroparesis patients over a 5-year period. Methods: 54 patients (mean age 41y; 78% female; 67% white,) who underwent permanent GES implantation between March 2007 and February 2016 were evaluated retrospectively. All patients were on prokinetic medications prior to the GES. 30 patients were diabetic, 24 non-diabetic (20 idiopathic and 4 post-surgical). Patients were seen prior to GES implant and approximately every 3 months thereafter. The use of prokinetic medication was assessed at baseline and at each clinic visit. Individual medication i.e. metoclopramide, domperidone, erythromycin and tricyclic acid (nortriptyline and amitriptyline) was also reviewed. Results: All patients had received GES therapy for five years. The use of prokinetic medications decreased from 49/54 (91%) at baseline to 13/31 (42%) at 1 year, 10/24 (42%) at 3 years and 6/15 (40%) at 5 years (p=0.0001, p=0.0001 and p=0.0001, respectively). All changes were compared to the pre-GES baseline use of any prokinetic drug. In patients with diabetes, the use of prokinetic medications at baseline was 28/30 (93%). This decreased to 11/16 (69%) at 1 year, 7/15 (47%) at 3 years and 4/8 (50%) at 5 years (p=0.04, p=0.0009 and p=0.01, respectively). In non-diabetics, 21/24 (88%) patients were on prokinetics. At 1 year after GES, 2/15 (13%, p=0.0001), at 3 years 3/9 (33%, p= 0.005) and at 5 years 2/7 (29%, p=0.006) patients continued to use prokinetic medications (Table 1). Metoclopramide was the most commonly used prokinetic 46/49 (94%) followed by domperidone 36/49 (73%) and erythromycin 32/49 (65%). The use of each individual prokinetic medication decreased over the five-year period (Table 2). Similar, statistically significant benefits were seen at years 2 and 4 after GES. 4 patients had adverse effect from the GES, infection being the most common. Side effects of prokinetics, particularly sedation were reported in a majority of patients. Conclusion: GES treatment in patients with medically refractory gastroparesis leads to a sustained decrease in the long-term need for prokinetic medications. This benefit is seen in all etiologies of gastroparesis. Currently available prokinetic medications are associated with frequent adverse effects and have risk of serious complications including cardiac dysrhythmias and extrapyramidal involuntary movements. Patients presenting with severe gastroparesis should be evaluated early for GES therapy. Table 1: Percentage of patients requiring prokinetic medications at baseline, 1, 3 and 5 years after GES
Su1563 LONG TERM EFFICACY OF GASTRIC ELECTRICAL STIMULATION FOR POST-SURGICAL GASTROPARESIS Alex Pontikos, Imad Jaafar, Nikhil Kadle, Endashaw Omer, Abigail Stocker, Lindsay McElmurray, Ed Miller, Michael G. Hughes, Thomas Abell Introduction: Gastric electrical stimulation (GES) has been used for the treatment of gastroparesis (Gp) caused by a variety of conditions, including post surgical disorders. The relative efficacy of GES is unknown in post-surgical Gp compared to diabetic and idiopathic Gp. We aimed to compare the effectiveness of GES in post-surgical (PS) gastric motor conditions vs diabetes mellitus (DM) and idiopathic (ID) Gp by examining short term treatment with temporary GES followed by long term outcome of permanent GES. Patients: We examined the records of 202 patients with permanent GES placement of at least 12 months' duration. Patients' ages ranged from 14-78 with 83.7% women and 16.3% men with a mean age of 42.6 years old. Underlying etiologies for Gp were post-surgical (10.9%), diabetic (26.2%), and idiopathic (62.9%). Patients reported symptoms (vomiting, nausea, anorexia, bloating, pain 0-4 each and total score=TSS) by a standardized patient reported outcome (PRO), as previously reported (GIE 74(3): 496-503). Of the 22 PS patients, 5 had Nissen fundoplication, 5 had Rou-en-Y gastric bypass, 4 had previous laparoscopic bands, and 8 patients had related operations. Methods: All patients underwent baseline evaluation for symptoms prior to GES placement, then evaluation post endoscopic temporary GES (up to one week), followed by long-term evaluation averaging at least 12 months. We compared GI symptoms by PRO for 202 patients at 12 months (PS, DM and ID) including 195 of those patients who had a temporary GES first, to see if any of the three groups benefitted more than the others with particular attention to the PS patients. Results were compared by t-tests and reported as mean and STD. Results: GI symptoms improved with temporary GES (5-7 days) and all symptoms including total GI symptoms (TSS) were improved as a group and by subgroup of Gp (PS, DM, and ID) (table 1). With permanent GES, all symptoms for the whole group were significantly improved after 12 months (mean of 420.7 days) as compared to baseline scores. Symptom improvement for post surgical patients, although improved for
S-521
AGA Abstracts
AGA Abstracts
upper endoscopy findings were determined. Data were analyzed using chi-square and p < 0.05 was considered significant. Results: 98 patients with GP were identified (10 males and 88 females, age range 19-81 yrs). 20% of the GP subjects (n=20) had 3 cpm GMA, the functional obstructive GP subtype. These 20 GP patients were 18 women and 2 men, average age 41. 80% of the patients (n=78) had gastric dysrhythmias (39 tachygastria, 12 bradygastria and 27 mixed dysrhythmias). These patients were 71 women and 7 men, average age 50. Meal retention at 2 hr and 4 hr averaged 71% and 31% in the normal 3 cpm group and 65% and 32% in the gastric dysrhythmia group. Ingested water volume averaged 509 mL in the normal 3 cpm group and 522 mL in the dysrhythmia group. GP patients with normal 3 cpm rhythm were less likely to have DM (15% v. 41%, p = 0.03), hypothyroidism (5% v. 27%, p=0.04), elevated BMI (25% v. 69%, p < 0.001) and more likely to have endoscopic findings suggestive of pyloric dysfunction, (pylorospasm, tight pylorus or difficulty traversing the pylorus) (55% v 9%, p < 0.001). Patients with GP and normal 3 cpm GMA more frequently received dicyclomine (47% v. 24%, p = 0.047). The majority of patients in both groups had undergone cholecystectomy (63% v 55%, p = 0.52). Similar numbers of patients in each group had depression, anxiety, fibromyalgia or migraine headaches, smoking history and active narcotics or proton pump inhibitors use. Conclusions: 1. Patients with functional obstructive GP with 3 cpm subtype are younger, have significantly lower BMI and are less likely to have diabetes mellitus or hypothyroidism compared with patients with GP and gastric dysrhythmias; 2. Pyloric findings were noted in half of the patients with 3 cpm GMA, and also supports the diagnosis of functional obstructive GP with 3 cpm GMA ; and 3. 20% of patients with GP had normal 3 cpm GMA, suggesting functional gastric outlet obstruction is relatively common and should be considered in evaluating patients with GP.
Su1562 THE SAFETY PROFILE OF WIRELESS MOTILITY CAPSULE IN PATIENTS WITH SUSPECTED MULTIREGIONAL GASTROINTESTINAL DYSMOTILITY Gengqing Song, Cynthia Funk, Jan Santisi, Jack Semler, Michael S. Cline
Su1561 CONCOMITANT USE OF PROKINETIC MEDICATIONS AFTER GASTRIC ELECTRICAL STIMULATION IN PATIENTS WITH MEDICALLY REFRACTORY GASTROPARESIS OVER A 5-YEAR PERIOD Anam Hameed, Shamim Ejaz, Gladis A. Shuttlesworth, John R. Stroehlein, Mehnaz Shafi
BACKGROUND: Wireless motility capsule (WMC) provides a full gastrointestinal (GI) tract transit profile in patients with GI dysmotility and may be able to detect and diagnose multiregional dysmotility. However, there is limited published data available to assess the safety profile of WMC. AIMS: To investigate the safety profile of WMC in patients with upper and lower GI symptoms suggestive of multiregional GI dysmotility. METHODS: Retrospective chart review of 700 patients who presented with nausea, vomiting, early satiety, and / or constipation and had undergone WMC testing for suspected multiregional GI dysmotility from January 2009 to November 2016 at Cleveland Clinic was performed. After an overnight fast, subjects ingested a nutrient bar (260 kcal) followed by the WMC capsule, and wore the data receiver for 5 days. The patients discontinued all laxatives and drugs (including narcotics) that affect motility for 48 hours and PPI for 7 days before the study. Capsule retention was defined as capsule retention in the GI tract for more than 5 days. RESULTS: 1). An analysis of 700 WMC tests revealed 14 reports (8 females, mean age 54 with a standard deviation of 15) of prolonged capsule retention greater than 5 days (11 in the stomach and 3 in the small intestine), corresponding to a prolonged retention rate of 2%. In addition, 1 incidence of equipment or software malfunction prevented the acquisition of interpretable transit data from the WMC. 2). In 14 capsule retentions, all patients had gastroparesis, including 6 diabetic, 5 idiopathic, and 3 postsurgical. 3). In 11 of 14 cases spontaneous passage of the capsule was confirmed via sequential radiograph imaging. 4). Two of the remaining cases had capsules retained in the stomach and required upper endoscopy (EGD) for extraction. In 1 case, a patient had chronic abdominal pain and complained of worsening pain. In the second case, pyloric stenosis was identified and endoscopic pyloroplasty was performed after the WMC test. 5). The remaining prolonged retention underwent partial resection of the small bowel due to small bowel intussusception which was not identified on prior testing including small bowel follow through, computerized tomography and EGD. CONCLUSIONS: 1) WMC is a safe procedure. 2). A capsule retained in the stomach may necessitate EGD and may be monitored by sequential radiograph imaging. 3) Capsule retention in the stomach or small bowel that does not spontaneously resolve may signify an anatomic cause requiring further intervention.
Introduction: Gastric Electrical Stimulation (GES) is an FDA approved therapy for upper gastrointestinal (GI) symptoms in patients with medically refractory gastroparesis. Patients are invariably on prokinetic medications prior to GES. It is unclear how many patients no longer require prokinetic medications after GES implantation. Aim: To assess the continued, long term use of prokinetic medications after placement of the GES device in gastroparesis patients over a 5-year period. Methods: 54 patients (mean age 41y; 78% female; 67% white,) who underwent permanent GES implantation between March 2007 and February 2016 were evaluated retrospectively. All patients were on prokinetic medications prior to the GES. 30 patients were diabetic, 24 non-diabetic (20 idiopathic and 4 post-surgical). Patients were seen prior to GES implant and approximately every 3 months thereafter. The use of prokinetic medication was assessed at baseline and at each clinic visit. Individual medication i.e. metoclopramide, domperidone, erythromycin and tricyclic acid (nortriptyline and amitriptyline) was also reviewed. Results: All patients had received GES therapy for five years. The use of prokinetic medications decreased from 49/54 (91%) at baseline to 13/31 (42%) at 1 year, 10/24 (42%) at 3 years and 6/15 (40%) at 5 years (p=0.0001, p=0.0001 and p=0.0001, respectively). All changes were compared to the pre-GES baseline use of any prokinetic drug. In patients with diabetes, the use of prokinetic medications at baseline was 28/30 (93%). This decreased to 11/16 (69%) at 1 year, 7/15 (47%) at 3 years and 4/8 (50%) at 5 years (p=0.04, p=0.0009 and p=0.01, respectively). In non-diabetics, 21/24 (88%) patients were on prokinetics. At 1 year after GES, 2/15 (13%, p=0.0001), at 3 years 3/9 (33%, p= 0.005) and at 5 years 2/7 (29%, p=0.006) patients continued to use prokinetic medications (Table 1). Metoclopramide was the most commonly used prokinetic 46/49 (94%) followed by domperidone 36/49 (73%) and erythromycin 32/49 (65%). The use of each individual prokinetic medication decreased over the five-year period (Table 2). Similar, statistically significant benefits were seen at years 2 and 4 after GES. 4 patients had adverse effect from the GES, infection being the most common. Side effects of prokinetics, particularly sedation were reported in a majority of patients. Conclusion: GES treatment in patients with medically refractory gastroparesis leads to a sustained decrease in the long-term need for prokinetic medications. This benefit is seen in all etiologies of gastroparesis. Currently available prokinetic medications are associated with frequent adverse effects and have risk of serious complications including cardiac dysrhythmias and extrapyramidal involuntary movements. Patients presenting with severe gastroparesis should be evaluated early for GES therapy. Table 1: Percentage of patients requiring prokinetic medications at baseline, 1, 3 and 5 years after GES
Su1563 LONG TERM EFFICACY OF GASTRIC ELECTRICAL STIMULATION FOR POST-SURGICAL GASTROPARESIS Alex Pontikos, Imad Jaafar, Nikhil Kadle, Endashaw Omer, Abigail Stocker, Lindsay McElmurray, Ed Miller, Michael G. Hughes, Thomas Abell Introduction: Gastric electrical stimulation (GES) has been used for the treatment of gastroparesis (Gp) caused by a variety of conditions, including post surgical disorders. The relative efficacy of GES is unknown in post-surgical Gp compared to diabetic and idiopathic Gp. We aimed to compare the effectiveness of GES in post-surgical (PS) gastric motor conditions vs diabetes mellitus (DM) and idiopathic (ID) Gp by examining short term treatment with temporary GES followed by long term outcome of permanent GES. Patients: We examined the records of 202 patients with permanent GES placement of at least 12 months' duration. Patients' ages ranged from 14-78 with 83.7% women and 16.3% men with a mean age of 42.6 years old. Underlying etiologies for Gp were post-surgical (10.9%), diabetic (26.2%), and idiopathic (62.9%). Patients reported symptoms (vomiting, nausea, anorexia, bloating, pain 0-4 each and total score=TSS) by a standardized patient reported outcome (PRO), as previously reported (GIE 74(3): 496-503). Of the 22 PS patients, 5 had Nissen fundoplication, 5 had Rou-en-Y gastric bypass, 4 had previous laparoscopic bands, and 8 patients had related operations. Methods: All patients underwent baseline evaluation for symptoms prior to GES placement, then evaluation post endoscopic temporary GES (up to one week), followed by long-term evaluation averaging at least 12 months. We compared GI symptoms by PRO for 202 patients at 12 months (PS, DM and ID) including 195 of those patients who had a temporary GES first, to see if any of the three groups benefitted more than the others with particular attention to the PS patients. Results were compared by t-tests and reported as mean and STD. Results: GI symptoms improved with temporary GES (5-7 days) and all symptoms including total GI symptoms (TSS) were improved as a group and by subgroup of Gp (PS, DM, and ID) (table 1). With permanent GES, all symptoms for the whole group were significantly improved after 12 months (mean of 420.7 days) as compared to baseline scores. Symptom improvement for post surgical patients, although improved for
S-521
AGA Abstracts