0016-5107/95/4204-033055.00+ 0 GASTROINTESTINALENDOSCOPY Copyright© 1995by the AmericanSocietyfor GastrointestinalEndoscopy
Predictive factors for early mortality after percutaneous endoscopic gastrostomy Victoria L. Light, MD, Frederick A. Slezak, MD, Joel A. Porter, MD Lowell W. Gerson, PhD, Gary McCord, MA Akron and Rootstown, Ohio Background: Percutaneous endoscopic gastrostomy (PEG) is a safe access procedure for enteral nutrition. The purpose of this investigation is to identify predictive factors for early mortality after PEG. Methods: A retrospective review of the hospital records of 416 patients undergoing PEG from June 1,1989, through December 31,1991, was conducted. Patient demographics, admitting diagnosis, indication for PEG, risk factors for early mortality, and cause and date of death were reviewed. Logistic regression analysis was used to develop a model to predict early mortality after PEG. The follow-up period ranged from 1 to 30 months. Results:The overall mortality rate in this review was 227 of 416 patients (54.6%). The 7- and 30-day case fatality rates were 39 of 416 (9.4%) and 97 of 416 (23.3%), respectively. Logistic regression analysis showed that urinary tract infection (odds ratio (OR) = 3.05; 95% confidence interval (CI) = 1.45 - 6.43) and previous aspiration (OR = 6.86; 95% CI = 3.27 - 14.4) were predictive factors for death at 1 week after PEG. Patients who had both risk factors had a 48.4% probability of dying within 7 days after PEG insertion, whereas those who had no risk factors had a 4.3% probability of death. Urinary tract infection (OR = 2.00; 95% CI = 1.17 - 3.41), previous aspiration (OR = 3.62; 95% CI = 2.00 - 6.55), and age greater than 75 years (OR = 2.49; 95% CI = 1.47 - 4.21) were predictive factors for death at 1 month after PEG. Patients who had all three risk factors had a 67,1% probability of death at I month while those who had no risk factors had a 10% probability of death. Conclusions: A subgroup of patients exists that has a very high mortality rate after PEG. Less invasive ways of nutritionally supporting these high-risk patients should be evaluated. (Gastrointest Endosc 1995;42:330-5.)
E n t e r a l n u t r i t i o n is the r o u t e of choice in patients w i t h functional gastrointestinal tracts. Endoscopic p l a c e m e n t o f p e r c u t a n e o u s feeding tubes is a common m e t h o d for long-term e n t e r a l feeding. 114 The two most c o m m o n p e r c u t a n e o u s endoscopic g a s t r o s t o m y (PEG) techniques were developed by G a u d e r e r et al. 1 in 1980 and Russell et al. s in 1984. Reported Received April 15, 1994. For revision May 24, 1994. Accepted December 1, 1994. From the Department of Surgery, Akron City Hospital, Akron, Ohio, and the Division of Community Health Sciences, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio. Reprint requests: Frederick A. Slezak, MD, 55Arch Street, Suite 3D, Akron, Ohio 44304.
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30-day p o s t - P E G m o r t a l i t y has r a n g e d from 4.1% to 26.1%.2-4, 13, 15, 16-22 E m p h a s i s has been placed on the a p p r o p r i a t e and careful selection of candidates for PEG. 17-26 The purpose of this investigation is to identify predictive factors for early m o r t a l i t y after P E G insertion.
MATERIALS AND METHODS A retrospective review of the medical records of 416 patients who had PEG placement by two attending surgeons at Akron City Hospital between June 1, 1989, and December 31, 1991, was conducted. The PEG procedure was completed in the endoscopy suite, at the bedside, or in the operating room if a second procedure was performed. All patients received prophylactic antibiotics (a first-generation cephalosporin if they were not already receiving VOLUME 42, NO. 4, 1995
antibiotic treatment). Heart rate, blood pressure, and oxygen saturation were recorded for each patient. Routine suctioning was provided by nursing personnel. Sedation, if needed, was accomplished with intravenous meperidine (Demerol), midazolam (Versed), or both, on an individual basis. Lidocaine (Xylocaine) spray 10% was available for anesthesia of the posterior pharynx. A complete esophagogastroduodenoscopy was performed in each patient to identify any mucosal or obstructive abnormalities. The retrograde pull (string) technique as described by Gauderer and Ponsky 1 was utilized in 415 cases. The Russell split sheath introducer technique 15 was used in one case. After satisfactory completion of the procedure, povidone-iodine ointment and a sterile dressing were applied to the abdominal skin site. Postprocedure instructions included the use of an abdominal binder to prevent inadvertent dislodgement of the tube, elevation of the head of the bed, and immediate administration of medications per PEG tube. Feedings, either continuous or bolus, were begun within 12 to 24 hours after the procedure if there was evidence of adequate bowel function. Tension was also adjusted on the skin T-bar by pulling it back from the skin a few millimeters in order to avoid peristomal skin excoriation and fascial necrosis. The nursing staffchecked residuals every 4 hours and withheld tube feedings if residuals were greater than 100 cc/4 hours. Patients were followed by the general surgical service until feedings were tolerated. Patient demographics, admitting diagnosis, and indication for PEG were obtained in the chart review. Risk factors for surgery have been previously evaluated. 27-31 On the basis of published literature as well as the senior authors' combined personal experience of nearly 2000 PEGs, 12, 32-35 risk factors hypothesized to be contributors to early mortality were reviewed (Table 1). These proposed risk factors were divided into five groups: (1) preexisting medical conditions such as diabetes mellitus, coronary artery disease, recent myocardial infarction (<6 mos), chronic obstructive pulmonary disease, concurrent infection (urinary tract infection, pneumonia, leukocytosis [WBC count >10,800/mm 3] or other), previous documented aspiration or anemia (Hgb level <10.0 g/dL); (2) malnutrition or debilitation as evidenced by low albumin level (<3.0 g/dL) or extended intensive care unit stay; (3) impaired immunity such as advanced age or steroid use; (4) socioeconomic factors such as gender, smoking status, or lower socioeconomic class (no insurance or medicaid); and (5) surgical complications such as early tube withdrawal, post-PEG aspiration, or wound infection. Urinary tract infection was defined by positive urine culture (> 100,000 cfu/hpi). Pneumonia was confirmed by roentgenographic evidence of infiltration and positive sputum culture if obtainable. Previous aspiration was documented on clinical criteria or direct observation via cookie swallow. Post-PEG aspiration was determined by clinical examination and roentgenographic findings. Fever was not evaluated in the chart review. No patient who had a PEG placed was clinically septic. Causes and dates of death were obtained from the hospital chart for patients who died in the hospital or from the Ohio Department of Health, Data Services Division, Mortality Tapes 1989-1991, for those V O L U M E 42, NO. 4, 1995
Table 1. Hypothesized contributors to early mortality Preexisting medical conditions Diabetes mellitus Coronary artery disease Recent myocardial infarction (<6 mos) Chronic obstructive pulmonary disease Concurrent infection (pneumonia, urinary tract infection, leukocytosis WBC >10,800/mm3, or other) Previous documented aspiration Anemia (Hgb <10.0 g/dL) Malnutrition or debilitation Low albumin (<3.0 g/dL) Extended intensive care unit stay Impaired immunity Advanced age Steroid use Socioeconomic factors Gender Smoking status Socioeconomic class-insurance status Surgical complications Early tube withdrawal Post-PEG aspiration Wound infection
who died following hospital discharge. All patients were followed for a minimum of 30 days. The longest follow-up was 30 months. Logistic regression analysis was performed to develop a model to predict early mortality after PEG placement. The first step in building the model was to perform simple comparisons between post-PEG patients who died early and those patients who survived. Significant factors (chi-squared p < 0.05) in the unadjusted analysis were then entered into the logistic regression. Odds ratios (OR) with 95% confidence intervals (95% CI) were calculated for statistically significant factors in the model.
RESULTS D u r i n g the s t u d y period, 416 p a t i e n t s received P E G p l a c e m e n t a t A k r o n City Hospital. T h e p a t i e n t s r a n g e d in age f r o m 18 to 103 y e a r s ( M e a n age, 74.7 years). T h e r e w e r e 217 w o m e n a n d 199 m e n included in the study. T h e 7- a n d 30-day case f a t a l i t y r a t e s w e r e 9.4% (39) a n d 23.3% (97). Overall, 227 of 416 (54.6%) of t h e p a t i e n t s died over t h e s t u d y period. T h e m o s t c o m m o n a d m i t t i n g diagnosis w a s cereb r o v a s c u l a r accident, 23.8% (99 of 416), followed b y p n e u m o n i a 17.3% (72), cancer 11.8% (49), m a l n u t r i tion 9.9% (41), u r i n a r y t r a c t infection 6.9% (29), cardiac disorders 6.0% (25), t r a u m a 5.8% (24), gast r o i n t e s t i n a l disorders 5.0% (21) a n d o t h e r medical p r o b l e m s 13.5% (56). T h e indications for P E G included c e r e b r o v a s c u l a r accident 29.6% (123 of 416), m a l n u t r i t i o n 16.8% (70), r e s p i r a t o r y failure 13.9% (58), d e m e n t i a 10.6% (44), h e a d a n d n e c k c a n c e r 9.1% (38), d y s p h a g i a 7.0% (29), a s p i r a t i o n 6.7% (28), cancer (excluding h e a d a n d GASTROINTESTINAL ENDOSCOPY
Table 2. Causes of death* after PEG placement (N = 416) Number of patients deceased Cause At 1 week At 1 month Cerebrovascular accident 9 22 Cardiac (MI, CHF) 9 20 Cancer 6 16 Pulmonary (Pneumonia, COPD) 5 15 Dementia 5 8 Gastrointestinal disease 1 3 Chronic renal failure 1 2 Urosepsis 1 2 Rheumatoid arthritis 1 2 Trauma 1 5 Diabetes mellitus 0 1 Anemia 0 1 Total 39 97 MI, Myocardial infarction; CHF, congestive heart failure; COPD, chronic obsmactive pulmonary disease. *Causes of death were obtained from the hospital chart or the Ohio Department of Health, Data Services Division, Mortality Tapes 1989-1991.
neck) 1.4% (6) a n d o t h e r indications (i.e., t r a u m a ) 4.8% (20). H e m o g l o b i n v a l u e s r a n g e d f r o m 6.3 to 18.8 g m / d L (mode = 10.9 gm/dL). A l b u m i n v a l u e s r a n g e d f r o m 1.3 to 4.5 grrgdL (mode = 3.0 gnddL). W h i t e blood cell count r a n g e d f r o m 0.4 to 33.6 t h o u s a n d / m m 3 (mode = 10.2 thousand/mm3). T h e m o s t c o m m o n c a u s e of d e a t h a t i w e e k a n d 1 m o n t h w a s c e r e b r o v a s c u l a r accident. O t h e r c a u s e s of d e a t h are listed in T a b l e 2. N i n e t y - o n e of 416 p a t i e n t s (22%) h a d complications. T h e m o s t c o m m o n complications included p o s t - P E G a s p i r a t i o n (67), w o u n d infection (10), a n d p r e m a t u r e w i t h d r a w a l of t h e P E G t u b e (6). P r e m a t u r e w i t h d r a w a l of the t u b e w a s t r e a t e d b y r e p e a t P E G if t h e e v e n t occurred less t h a n 30 d a y s following t h e original P E G or replaced p e r c u t a n e o u s l y if t h e e v e n t occurred a f t e r 30 days. No l a p a r o t o m i e s w e r e required. T w e n t y - n i n e of 67 p a t i e n t s w i t h p o s t - P E G a s p i r a t i o n died (43.3%). Five of 10 patients w i t h w o u n d infection died (50%). Two of 6 p a t i e n t s w i t h e a r l y w i t h d r a w a l of t h e P E G t u b e died (33%). Statistically significant crude contributors to e a r l y m o r t a l i t y a f t e r P E G included: u r i n a r y t r a c t infection, m y o c a r d i a l infarction w i t h i n the p a s t 6 m o n t h s , cancer (excluding h e a d a n d neck), age g r e a t e r t h a n 75 years, a n d p r e v i o u s l y d o c u m e n t e d a s p i r a t i o n (chis q u a r e d p < 0.05). T h e r e w e r e 104 p a t i e n t s w i t h urin a r y t r a c t infections. P r e v i o u s h i s t o r y of a s p i r a t i o n w a s d o c u m e n t e d in 128 p a t i e n t s . O f 416 p a t i e n t s , 245 w e r e older t h a n 75 y e a r s of age. T h e logistic r e g r e s s i o n r e v e a l e d two statistically
Table 3. Predicted probability of death after PEG Deceased (%) Risk factors At i week At 1 month None 4.3 10.0 Urinary tract infection 12.0 18.5 Previous aspiration 24.0 29.1 Age >75 years* -22.0 Urinary tract infection + -36.0 age >75 years Urinary tract infection + 48.4 45.1 previous aspiration Age >75 years + previous aspiration -50.5 Urinary tract infection + -67.1 age >75 years + previous aspiration *Note that age >75 years was not a statistically significant risk factor for death at 1 week.
significant factors for m o r t a l i t y a t 1 w e e k following PEG: u r i n a r y t r a c t infection (OR = 3.05; 95% CI = 1 . 4 5 - 6 . 4 3 ) a n d previous h i s t o r y of a s p i r a t i o n (OR = 6.86; 95% CI = 3.47 - 14.4). P a t i e n t s possessing n e i t h e r of t h e r i s k factors h a d a 4.3% p r o b a b i l i t y of d e a t h w i t h i n 1 w e e k following PEG. P a t i e n t s who h a d one r i s k factor h a d b e t w e e n 12.0% to 24.0% probability of death, w h e r e a s p a t i e n t s h a v i n g b o t h r i s k factors h a d a 48.4% p r o b a b i l i t y of d e a t h at 1 w e e k (Table 3). T h r e e factors w e r e statistically significant for mortality a t 1 m o n t h a f t e r PEG: u r i n a r y t r a c t infection (OR = 2.00; 95% CI = 1.17 - 3.41), age g r e a t e r t h a n 75 y e a r s (OR = 2.49; 95% CI = 1.47 - 4.21), a n d previous a s p i r a t i o n (OR = 3.62; 95% CI = 2.00 - 6.55). P a t i e n t s p o s s e s s i n g none of t h e r i s k factors h a d a 10.0% probability of d e a t h a t 1 m o n t h following PEG. P a t i e n t s w i t h one r i s k factor h a d b e t w e e n 18.5% a n d 29.0% p r o b a b i l i t y of d e a t h at 1 m o n t h while p a t i e n t s h a v i n g all t h r e e r i s k factors h a d a 67.1% p r o b a b i l i t y of d e a t h at 1 m o n t h (Table 3).
DISCUSSION N u t r i t i o n a l s u p p o r t can be quite challenging. Adv a n t a g e s of e n t e r a l n u t r i t i o n over p a r e n t e r a l nutrition a r e well k n o w n a n d include lower cost, i n c r e a s e d safety, b e t t e r p a t i e n t tolerance, m a i n t e n a n c e of struct u r a l g a s t r o i n t e s t i n a l integrity, a n d i n c r e a s e d resist a n c e a g a i n s t infection. 36, 37 T h e p e r c u t a n e o u s a p p r o a c h to g a s t r o s t o m y t u b e p l a c e m e n t w a s first described b y G a u d e r e r et al. in 1980.1 S e v e r a l a d v a n t a g e s of t h e p e r c u t a n e o u s app r o a c h c o m p a r e d to o p e r a t i v e g a s t r o s t o m y are the u s e of local a n e s t h e s i a , d e c r e a s e d p r o c e d u r e time, ability to p e r f o r m the p r o c e d u r e in t h e endoscopy suite or at t h e bedside, a n d d e c r e a s e d cost a n d earlier feeding a f t e r p l a c e m e n t . 1, 3, 5-9, 15, 38 H o w e v e r , P E G place-
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ment, like any invasive procedure, is not entirely benign. As PEG has gained wide acceptance over the past decade, numerous reports have described the clinical experience, indications, limitations, and complications of PEG.* Absolute contraindications to PEG include pharyngeal-esophageal obstruction, inability to perform endoscopy, and uncorrectable coagulopathy.2, 4, 5,10 Reported post-PEG 30-day mortality has ranged from 4.1% to 26.0% 2-4' 13,15,16-22 (Table 4). Emphasis in many of the studies has been placed on the appropriate and careful selection ofcandidates for PEG. 1%26 Clarkston et al.19 suggested that many patients do not survive long enough to receive the maximal benefit from PEG, which in itself was designed to provide long-term nutritional support. 19 Wolfsen et al.20 similarly stated that the benefits of PEG are limited in patients with a projected early mortality. We attempt to delineate prognostic factors for early mortality following PEG. Other attempts to characterize this high-risk subgroup of patients have been made. 18,19,21-23,4° Diteshelm et al.23 reviewed seven patients with PEG placement, four of whom died. The cause of death was caused by a lack of adhesion formation between the gastric serosa and the anterior abdominal wall, resulting in intraperitoneal contamination with gastric contents. Poor nutritional status and steroids were implicated as causative factors and considered relative contraindications to PEG placement. Neither poor nutritional status nor steroid usage were implicated as predictors of mortality in our study. Taylor et al.21 reviewed 97 patients who received a PEG and concluded that patients at high risk for 1-month mortality were older men, individuals with diabetes, and patients who had a PEG placed for cerebrovascular accident or oropharyngeal cancer. In our investigation, only advanced age was implicated as a predictor of mortality. Hassett et al. 41 studied 87 patients with gastrostomy tubes and found t h a t of 29 patients who aspirated before gastrostomy, 18 continued to aspirate. They concluded that the preoperative presence of both gastroesophageal reflux and aspiration was associated with postoperative aspiration in all patients and that the continued presence of aspiration was associated with a significant increase in mortality. Our study concurs that aspiration is a contributor to early mortality after PEG. It is bothersome, however, t h a t previous aspiration was a contributor to early mortality when aspiration was an actual indication for PEG in 28 of 416 patients (6.7%). Perhaps in future studies the cause of aspiration (difficulty handling secretions or gastroesophageal reflux) can be delineated. Another interesting addendum would be to compare pa*References 2-4, 6, 17, 19, 20, 22-24, 39
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Table 4. PEG mortality study comparisons No. of
K i r b y e t al. 13 (1986) S t e r n e t al. 15 (1986) L a r s o n e t al. 4 (1987) F o u t c h e t al. TM (1988) L l a n e z a e t al. 17 (1988) S t e l l a t o e t al. i s (1988) S t e f f e s e t al. 3 (1989) M i l l e r e t al. 2 (1989) C l a r k s t o n e t al. 19 (1990) W o l f s e n e t al. 2° (1990) T a y l o r e t al. 21 (1992) J a r n a g i n e t al. 22 (1992) L i g h t e t al. (1994)
55 100 314 120 73 38 112 316 42 191 97 64 416
7-Day 30-Day mortality rate mortality rate
----4 --8 ----9.4
18 7 16 4.1 26 9 24 17 26 26 22.8 17 23.3
tients with tracheostomy and PEG versus PEG alone and contrast mortality rates and likelihood of aspiration.12 Percutaneous endoscopic j ejunostomy has been advocated as a potential solution to aspiration. However, m a n y recent studies refute this based on poor results,42, 43 including a high incidence of tube malfunction, gastrointestinal hemorrhage, 42 and persistent aspiration. 43 The 1-week case fatality rate in the present study was 9.4% (39 of 416), which is slightly higher t h a n previous reportsfl 17 Statistically significant factors for death within 1 week after PEG were urinary tract infection and previous aspiration. Patients who possessed both risk factors had a 48.4% probability of death at 1 week. The case fatality rate for 1 month was 23.3% (97 of 416), which is within the reported range in the literature.2-4, 13, 15, 16-22 Statistically significant risk factors for death at 1 month after PEG included the same factors as for 1 week (i.e., urinary tract infection, previous aspiration) but also included age greater t h a n 75 years. It is unclear as to why advanced age was a significant risk factor at 1 month but not at 1 week. Patients who possessed all three risk factors had a 67.1% probability of death at I month after PEG. Urinary tract infection, in itself, may be an indicator of the overall debilitating medical condition of some of these patients. We are uncertain as to the exact pathophysiology of urinary tract infection as a factor implicated in early mortality after PEG. There does appear, however, to be a high incidence of Foley catheter usage in these patients. In addition, hospitalized patients exposed to nosocomial organisms may have more virulent infections, which predispose them to complications. Perhaps any preexisting infection should be eradicated before PEG placement. This will
GASTROINTESTINAL ENDOSCOPY 3 3 3
be a major component of our future prospective PEG study. W e a r e i n a g r e e m e n t w i t h S t e i g i n a n n e t al. 3s t h a t a m e a n i n g f u l a s s e s s m e n t o f p a t i e n t s ill e n o u g h to r e q u i r e P E G is difficult. H o w e v e r , w e h a v e i d e n t i f i e d a subgroup of patients who have a very high mortali t y r a t e f o l l o w i n g P E G . L e s s i n v a s i v e w a y s to n u t r i tionally support these high-risk patients should be a d d r e s s e d . I t is r e a s o n a b l e to g i v e c e r t a i n h i g h - r i s k p a t i e n t s , n o t e x p e c t e d to s u r v i v e a n e x t e n d e d p e r i o d , a " g r a c e p e r i o d " o f 30 to 60 d a y s d u r i n g w h i c h t h e p a t i e n t r e c e i v e s n a s o g a s t r i c f e e d i n g s . 19 I f t h e p a t i e n t s u r v i v e s t h i s g r a c e p e r i o d , t h e y m a y b e c o n s i d e r e d for PEG. Careful small meal spoon feedings ofhigh-calo: rie, h i g h - p r o t e i n p u d d i n g s a s d e s c r i b e d b y C a m p b e l l T a y l o r a n d F i s h e r 44 m i g h t a l s o b e c o n s i d e r e d . Several potential limitations exist with the present study. First, because of the retrospective design, some information may be absent or inadequately docum e n t e d . A n o t h e r p o s s i b l e p r o b l e m is t h a t n u m e r o u s risk factors were evaluated. The likelihood of one or more factors being statistically significant by chance m a y b e h i g h , g i v e n t h e s a m p l e size. L a s t , t h e s t a t e of Ohio Vital Statistics may not include people who h a v e d i e d o u t s i d e o f Ohio. T h i s n u m b e r , h o w e v e r , w a s probably very small. REFERENCES 1. Gauderer MWL, Ponsky JL, Izant RJ. Gastrostomy without laparotemy: a percutaneous endoscopic technique. J Pediatr Surg 1980;15:872-5. 2. Miller RE, Castlemain B, Lacqua FJ, Kotler DP. Percutaneous endoscopic gastrostomy: results in 316 patients and review of the literature. Surg Endosc 1989;3:186-90. 3. Steffes C, Weaver DW, Bouwman DL. Percutaneous endoscopic gastrostomy: new technique--old complications.Am Surg 1989; 55:273-7. 4. Larson DE, Burton DD, Schroeder KW, DiMagno EP. Percutaneous endoscopic gastrostomy: indications, success, complications and mortality in 314 consecutive patients. Gastroenterology 1987;93:48-52. 5. Miller RE, Kummer BA, Tiszenkel HI, Kotler DP. Percutaneous endoscopic gastrostomy: procedure of choice. Ann Surg 1986;204:543-5. 6. Ponsky JL, Gauderer MWL, Stellato TA. Percutaneous endoscopic gastrostemy: review of 150 cases. Arch Surg 1983;118: 913-4. 7. Ponsky JL, Gauderer MWL, Stellate TA, Aszodi A. Percutaneous approaches to enteral alimentation. Am J Surg 1985;149: 102-5. 8. Russell TR, Brotman M, Norris F. Percutaneous gastrostomy: a new simplified and cost-effective technique. Am J Surg 1984; 148:132-7. 9. Scott JS, DeLaTorreRA, Unger SW. Comparison of operative versus percutaneous endoscopic gastrostomy tube placement in the elderly. Am Surg 1991;57:338-40. 10. Thatcher BS, Ferguson DR, Paradis K. Percutaneous endoscopic gastrostomy: a preferred method of feeding tube gastrostomy. Am J Gastroeuterol 1984;79:748-50. 11. Sangster W, Cuddington GD, Bachulis BL. Percutaneous endoscopic gastrostomy. Am J Surg 1988;155:677-9. 12. Slezak FA, Kofol WH. Combined tracheostemy and percutaneous endoscopic gastrostomy. Am J Surg 1987;154:271-3.
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N THE MOVE'? ~ e n d u s y o u r n e w a d d r e s s at l e a s t s i x w e e kk~s a h e a d
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