Double-balloon enteroscopy 21. Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the updated american geriatrics Society/British geriatrics society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc 2011; 59: 148–57. 22. Okura Y, Urban LH, Mahoney DW, Jacobsen SJ, Rodeheffer RJ. Agreement between self-report questionnaires and medical record data was substantial for diabetes, hypertension, myocardial

Age and Ageing 2015; 44: 529–532 doi: 10.1093/ageing/afv003 Published electronically 28 January 2015

infarction and stroke but not for heart failure. J Clin Epidemiol 2004; 57: 1096–103. 23. Ganz DA, Higashi T, Rubenstein LZ. Monitoring falls in cohort studies of community-dwelling older people: effect of the recall interval. J Am Geriatr Soc 2005; 53: 2190–4. Received 25 March 2014; accepted in revised form 10 October 2014

© The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: [email protected]

Double-balloon enteroscopy and outcomes in patients older than 80 DAVID J. CANGEMI1, MARK E. STARK2, JOHN R. CANGEMI2, FRANK J. LUKENS2, VICTORIA GÓMEZ2 1

Department of Internal Medicine, Mayo Clinic, 4500 San Pablo Road S, Jacksonville, FL 32224, USA Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA

2

Address correspondence to: D. J. Cangemi. Tel: (+1) 904 953 6722; Fax: (+1) 904 953 0662. Email: [email protected]; [email protected]

Abstract Background: double-balloon enteroscopy (DBE) is becoming more commonly used for investigation of small bowel pathology. Currently, there are limited data to describe its safety and efficacy in the population over age 65. Aim: to investigate the indications, findings and outcomes of DBE performed in patients older than 80, as well as the correlation between DBE and prior capsule endoscopy (CE) findings. Methods: we retrospectively reviewed our large DBE database, including procedures from January 2006 to September 2012. Patients aged 80 or older at the time of DBE were included in the study. The indications, findings, outcomes and diagnostic yield of DBE were calculated by frequency analysis. Results: two hundred and fifteen DBEs were performed in 130 patients aged 80 or older. The mean age was 83.6 ± 3.03 years (range: 80–94). Twelve patients (9.2%) were assigned an American Society of Anaesthesiologists score of II prior to procedure, 102 patients (78.4%) were assigned a score of III and 16 patients (12.3%) were given a score of IV. The most common indication for DBE was obscure gastrointestinal bleeding (N = 204, 94.9%). One hundred and fourteen patients (87.7%) underwent CE prior to DBE, and correlation between findings of CE and DBE occurred in 74.6% of these patients. The overall diagnostic yield of DBE was 77.2% (N = 166). There were no immediate post-procedural complications or failed procedures. Conclusion: DBE is a safe and effective technique for investigation of the small bowel in patients aged 80 and older. Age alone should not be a contraindication to performing DBE when clinically indicated. Keywords: double-balloon enteroscopy, capsule endoscopy, older people, complications

Introduction The number of people aged 85 and older in the USA is projected to increase from 5.5 million in 2010 to 6.6 million by 2020 [1]. This patient population has a higher prevalence of

co-morbidities, specifically anaemia and obscure gastrointestinal bleeding (OGIB) [2]. Double-balloon enteroscopy (DBE) is now widely recognised as a safe and effective modality for endoscopic evaluation of the small intestine, and its most common indication is evaluation of OGIB [3]. Developed in

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D. J. Cangemi et al. 2001 [4, 5], DBE not only allows for direct investigation of the entire small bowel mucosa, it also provides therapeutic options such as haemostasis, tissue biopsy and polypectomy. DBE is inherently more technically complex than standard esophagogastroduodenoscopy and colonoscopy; however, despite a prolonged duration, DBE has been proven to be a relatively safe procedure with a major complication rate as low as 0.72–1.2% [3, 6]. Mucosal perforation, pancreatitis, bleeding and aspiration pneumonia are the most common major complications associated with DBE [3]. To date, there are very limited data that address the safety and efficacy of DBE in older patients, particularly those over the age of 80. The aim of our study was to investigate the indications, findings and outcomes of DBE performed in octogenarians, as well as assess the correlation between DBE and prior capsule endoscopy (CE) findings.

Methods A retrospective chart review was conducted of a large database of all DBE procedures performed between January 2006 and September 2012 by two endoscopists (M.E.S., F.J.L.) at a single tertiary care institution. In many instances, patients underwent CE prior to DBE. In each case, informed consent was obtained and general anaesthesia was provided by an anaesthesia team. DBE was performed using the DoubleBalloon Enteroscopy System (Fujinon Inc., Wayne, NJ, USA), with the Fujinon EN-450T5 enteroscope and TS-13140 overtube (Fujinon), or the EN-450P5 enteroscope and TS-12140 overtube, respectively. The PB-10 Balloon Pump Controller (Fujinon) regulated balloon inflation. DBE was performed in an anterograde fashion, a retrograde fashion or both, dependent on the suspected location of the target lesion(s). Data recorded included patient demographic information, co-morbidities and American Society of Anaesthesiologists (ASA) score at the time of procedure. We also recorded DBE indication and approach, total procedure time, endoscopic findings, type of endoscopic intervention performed and prior CE findings. Correlation between CE and DBE findings was determined by whether the findings on DBE were consistent with those seen on prior CE. The safety and diagnostic yield of DBE were calculated by frequency statistics.

Results During this study period, 215 DBE procedures were performed in 130 patients ≥80 years of age. The mean age was 83.6 ± 3.03 years (range: 80–94) (Table 1). The majority (N = 94, 72.3%) of patients were between the ages of 80–85. One hundred and sixteen (89.2%) patients were known to have common co-morbidities such as hypertension, coronary artery disease and diabetes mellitus. Most patients (N = 102, 78.5%) were assigned an ASA score of III prior to the procedure, and 16 patients (12.3%) were assigned an ASA score of IV (highest ASA score).

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One hundred and twenty-three DBE procedures (57.2%) were performed in anterograde fashion (oral approach) and 92 (42.8%) were performed in a retrograde fashion (anal approach) (Table 2). The most common indication for DBE was OGIB (N = 204, 94.9%). Specifically, DBE was indicated for ‘occult’ OGIB in 146 (67.9%) procedures and for ‘overt’ OGIB in 58 (27%) procedures. The overall diagnostic yield of DBE, defined by cases in which pertinent positive findings were identified, was 77.2%. The diagnostic yield of DBE for gastrointestinal bleeding (occult and overt) was Table 1. Baseline demographic information of the study population (N = 137) Characteristics

Values

Gender (M/F) Age Mean Range 80–85 85–90 90+ ASA class, n (%) II III IV Co-morbidities, n (%) Hypertension Coronary artery disease Diabetes mellitus Prior cerebrovascular accident Chronic obstructive pulmonary disease Chronic kidney disease Prior capsule endoscopy, n (%)

73/57

........................................ 83.6 ± 3 years 80–94 years 94 patients (72.3%) 30 patients (23.1%) 6 patients (4.6%) 12 (9.2) 102 (78.5) 16 (12.3) 85 (65.4) 66 (50.7) 36 (27.7) 7 (5.1) 20 (15.4) 31 (22.6) 114 (87.7)

Table 2. Double-balloon enteroscopy procedure data (N = 223) Characteristics

Values

........................................ Indication, n (%) Occult OGIB Overt OGIB Suspected mass Small bowel obstruction Suspected Crohn’s disease Findings, n (%) Non-bleeding AVM Normal Bleeding AVM Mass Polyp Ulceration Stricture Other Therapeutic intervention, n (%) APC Polypectomy Mean procedure time (range) Route (upper/lower)

146 (67.9) 58 (27) 7 (3.2) 2 (0.9) 1 (0.5) 94 (43.7) 49 (22.8) 37 (17.2) 10 (4.7) 8 (3.7) 8 (3.7) 5 (2.3) 4 (1.9) 127 (59.1) 1 (0.5) 81.1 ± 29.7 min (12–168) 123/92

Double-balloon enteroscopy Table 3. Characteristics of small bowel tumours diagnosed by double-balloon enteroscopy Characteristics

Values

Finding, n (%) Adenocarcinoma Carcinoid Benign tissue GIST Leiomyoma Lymphangioma Metastatic disease

3 (30) 2 (20) 2 (20) 1 (10) 1 (10) 1 (10) 1 (10)

........................................

76.5%. The most common DBE findings were non-bleeding AVMs (N = 94 procedures, 43.7%). Eleven small bowel tumours were identified in 10 patients, and 4 patients (4/10; 40%) subsequently underwent a surgical intervention. The various pathologies of the lesions were as follows: adenocarcinoma (3/10 patients, 30%), carcinoid (2/10, 20%), normal small bowel mucosa (2/10, 20%), gastrointestinal stromal tumour (GIST) (1/10, 10%), leiomyoma (1/10, 10%), lymphangioma (1/10, 10%) and metastatic urothelial cell cancer (1/10, 10%). One patient was diagnosed with both adenocarcinoma and carcinoid tumour (Table 3). Average overall procedure time was 81.1 ± 29.7 min (range: 12–168 min). Therapeutic intervention was performed in 128 (59.5%) procedures. Argon plasma coagulation (APC) was the predominant form of intervention used, being performed in 127 procedures (99.2% of DBE procedures with intervention, 59.1% of total DBE procedures). Polypectomy was performed in one procedure (0.5% of DBE procedures with intervention, 0.8% of total DBE procedures). There were no immediate post-procedural complications noted within 48 h of the procedure being performed and no failed procedures. Prior to DBE, the majority (N = 107, 82.3%) of patients had undergone CE. Correlation between findings of CE and DBE occurred in 74.6% of these patients. If DBE is used as the standard, among the 20.6% (N = 22) of patients for whom there was no correlation between CE and DBE findings, false-positive CE findings were identified in 17 patients, and false-negative CE findings were noted in 5 patients. False-negative diagnoses by CE included five arteriovenous malformations (AVM).

Discussion As the population continues to grow older and the use of DBE becomes more widespread, there will be an increase in older patients referred for DBE for investigation of OGIB and other disorders more common among those over the age of 65, such as small bowel tumour [7]. Thus, the question of safety and efficacy of DBE in older patients is particularly relevant. Our retrospective single-centre study, which represents the largest cohort of patients aged 80 and over who underwent DBE, demonstrates that DBE is both safe and efficacious. We identified no major complications within 48 h of DBE being performed including anaesthesia-related

complication such as hypotension and oxygen desaturation, associated with the procedures. These results were consistent with a study performed by He et al. [8], which found no severe peri-procedural or post-procedural complications among 59 patients, aged 65 and older, who underwent DBE at a single tertiary centre in China. A similar study performed by Byeon et al. [9] in 167 patients, aged 75 and older, who underwent DBE at a single tertiary centre in the USA only identified three major complications—pancreatitis, hypoxia and aspiration pneumonia—that occurred in a total of 8 patients after DBE, all of which resolved with conservative care. Though we did not specifically record blood pressure readings before and after DBE, the aforementioned studies by He et al. [8] and Byeon et al. [9] found that levels of systolic and diastolic blood pressure only slightly decreased during DBE. Our study was unique in that we focussed on patients aged 80 and older. Despite the advanced age of our patient population, we acknowledge that there may be a question of inherent selection bias, such that only the ‘healthy’ older patients were allowed to proceed with DBE. However, we note that 90.8% of our patient population was assigned an ASA score of III or IV, indicating major systemic disease. Like the previous studies by He et al. and Byeon et al., our study found that the most common indication for DBE was OGIB. Non-bleeding AVM was the most common DBE finding among our patient population, as seen in 43.7% of all DBEs performed. However, therapeutic intervention ( predominantly APC) was performed in greater than half (59.1%) of all procedures. Our overall diagnostic yield of 77.2% was notably higher than the 60.3% yield observed by Byeon et al. and the 60.8% yield demonstrated by He et al. The overall diagnostic yield of DBE has previously been reported to be between 41 and 93.9% among various trials [3, 10, 11]. Therefore, based on our data, we postulate that the diagnostic yield of DBE in patients aged 80 and older is at least as great as that seen among the general population overall—and perhaps greater, though we acknowledge that a large percentage of our patient population (N = 97, 74.6%) had prior positive CE findings. However, of note, a recent study by Sidhu and Sanders, which compared DBE outcomes in 40 patients aged 70 and older with a cohort of younger patients, demonstrated a higher diagnostic yield for DBE in the former group (53%), compared with the latter (35%) [12]. Additionally, we noted a strong correlation between CE findings and DBE findings of 74.6%, compared with a correlation of 47.4% seen in the study by He et al. [8]. This study has several limitations. Its retrospective nature and lack of a control group of younger patients for purpose of direct comparison are two major limitations. Additionally, long-term outcomes beyond the 48 h post-procedure time period were not assessed and we did not record specific cardiopulmonary parameters such as blood pressure before and after DBE. Anaesthesiologist records were also not individually reviewed, but rather, the patient chart was reviewed for any major peri-procedural incidents. Finally, while complete visualisation of the small bowel was achieved with DBE in many data patients, data were not collected with regard to total

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D. J. Cangemi et al. enteroscopy rate. Without knowing the total enteroscopy rate, we acknowledge that DBE cannot be considered as the true gold standard for comparison with CE in our study. In conclusion, we report that DBE is a safe and effective technique for investigation of the small bowel in patients aged 80 and older. Further, DBE can be of great diagnostic and therapeutic value in this patient population, and findings correlate with those identified by CE. Though particular consideration should still be paid to the evaluation of the older patient prior to proceeding to DBE, we demonstrated that, as with other endoscopic procedures, age alone should not be a contraindication to performing DBE when clinically indicated.

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Key points • DBE is a safe and effective technique for investigation of the small bowel in patients over age 80. • DBE can be of great diagnostic and therapeutic value in patients over age 80, particularly in those with OGIB. • A strong correlation between CE and DBE findings can be seen in patients over age 80.

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Conflicts of interest

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None declared.

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References 12. 1. U.S. Department of Health and Human Services. A Profile of Older Americans: 2011-Administration on Aging. http://www. nlm.nih.gov/hsrinfo/aging_population_issues.html (2 April 2013, date last accessed). 2. Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and

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older in the United States: evidence for a high rate of unexplained anemia. Blood 2004; 104: 2263–8. Xin L, Liao Z, Jiang YP, Li ZS. Indications, detectability, positive findings, total enteroscopy, and complications of diagnostic double-balloon endoscopy: a systematic review of data over the first decade of use. Gastrointest Endosc 2011; 74: 563–70. Yamamoto H, Sekine Y, Sato Y et al. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc 2001; 53: 216–20. Yamamoto H, Kita H, Sunada K et al. Clinical outcomes of double-balloon endoscopy for the diagnosis and treatment of small-intestinal diseases. Clin Gastroenterol Hepatol 2004; 2: 1010–6. Moschler O, May AD, Muller MK, Ell C. Complications in double-balloon-enteroscopy: results of the German DBE register. Zeitschrift fur Gastroenterologie 2008; 46: 266–70. Cangemi DJ, Patel MK, Gomez V, Cangemi JR, Stark ME, Lukens FJ. Small bowel tumors discovered double-balloon enteroscopy: analysis of a large prospectively collected singlecenter database. J Clin Gastroenterol 2013; 47: 769–72. He Q, Zhang Q, Li JD et al. Double balloon enteroscopy in the old: experience from China. World J Gastroenterol 2012; 18: 2859–66. Byeon JS, Mann NK, Jamil LH. Double balloon enteroscopy can be safely done in elderly patients with significant comorbidities. J Gastroenterol Hepatol 2012; 27: 1831–6. Gerson LB. Outcomes associated with deep enteroscopy. Gastrointest Endoscopy Clin N Am 2009; 19: 481–96. Jeon SR, Kim JO, Kim HG et al. Changes over time in indications, diagnostic yield, and clinical effects of doubleballoon enteroscopy. Clin Gastroenterol Hepatol 2012; 10: 1152–6. Sidhu R, Sanders DS. Double-balloon enteroscopy in the elderly with obscure gastrointestinal bleeding: safety and feasibility. Eur J Gastroenterol Hepatol 2013; 25: 1230–4.

Received 25 March 2014; accepted in revised form 10 October 2014

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Double-balloon enteroscopy and outcomes in patients older than 80.

double-balloon enteroscopy (DBE) is becoming more commonly used for investigation of small bowel pathology. Currently, there are limited data to descr...
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