- Email: [email protected]
Safety of Outpatient Laparoscopic Cholecystectomy in the Elderly: Analysis of 15,248 Patients Using the NSQIP Database
Safety of Outpatient Laparoscopic Cholecystectomy in the Elderly: Analysis of 15,248 Patients Using the NSQIP Database Ajit Rao, BS, Antonio Polanco, BA, Sujing Qiu, BA, Joseph Kim, Celia M Divino, MD, FACS, Scott Q Nguyen, MD, FACS
MD,
Edward H Chin,
MD, FACS,
Studies have shown that laparoscopic cholecystectomy (LC) in an ambulatory setting is a safe alternative to the traditional overnight hospital stay. However, there are limited data on the morbidity and mortality of outpatient LC in elderly patients. We evaluated the safety of ambulatory LC in the elderly and identified risk factors that predict inpatient admission. STUDY DESIGN: A retrospective analysis was performed using the American College of Surgeon’s NSQIP database between 2007 and 2010. The database was searched for patients older than 65 years of age who underwent elective LC at all participating hospitals in the United States. Data from 15,248 patients were collected and we compared patients who underwent ambulatory procedures with those patients who were admitted for an inpatient stay. RESULTS: Seven thousand four hundred and ninety-nine (48.9%) patients were ambulatory and 7,799 (51.1%) were nonambulatory. Postoperative complications included mortality (0.2% vs 1.5%; p < 0.001), stroke (0.1% vs 0.3%; p < 0.001), myocardial infarction (0.1% vs 0.6%; p < 0.001), pulmonary embolism (0.1% vs 0.3%; p ¼ 0.005), and sepsis (0.2% vs 0.7%; p < 0.001) for ambulatory and nonambulatory cases, respectively. We identified significant independent predictors of inpatient admission and mortality, including congestive heart failure, American Society of Anesthesiologists class 4, bleeding disorder, and renal failure requiring dialysis. CONCLUSIONS: We believe ambulatory LCs are safe in elderly patients as demonstrated by low complication rates. We identified multiple risk factors that might warrant inpatient hospital admission. (J Am Coll Surg 2013;-:1e6. 2013 by the American College of Surgeons)
BACKGROUND:
Laparoscopic cholecystectomy (LC) is currently the accepted treatment for symptomatic gallstone disease, and remains one of the most frequently performed surgical procedures.1,2 Rapid recovery and excellent surgical outcomes have led to progressively shorter hospital stays.3 In recent years, outpatient LC has gained popularity and is now widely accepted and practiced in the United States.4 Multiple studies have demonstrated that LC in an ambulatory setting is a safe alternative to the traditional overnight hospital stay.5,6
Several studies have examined risk factors that predispose patients to a longer hospital stay after LC, with age older than 65 as a risk factor.7,8 However, there are limited data on higher postoperative complications in elderly patients who are discharged several hours after surgery compared with those who are admitted for overnight observation, and uncertainty exists on the safety of outpatient LC in the elderly. This is a 4-year retrospective study examining a large, nationwide database to investigate the postoperative complication rate in patients 65 years of age or older undergoing elective, outpatient LC.
CME questions for this article available at http://jacscme.facs.org
METHODS
Disclosure Information: Authors have nothing to disclose. Timothy J Eberlein, Editor-in-Chief, has nothing to disclose.
Data source A retrospective analysis was performed using the American College of Surgeon’s NSQIP dataset between 2007 and 2010. The NSQIP database was originally developed within the Veterans Health Administration System and was later expanded to the private sector by the
Received June 29, 2013; Revised August 1, 2013; Accepted August 1, 2013. From the Department of Surgery, Mount Sinai Medical Center, New York, NY. Correspondence address: Scott Q Nguyen, MD, Department of Surgery, Mount Sinai Medical Center, 5 E 98th St, Box 1259, New York, NY 10029. email: [email protected]
ª 2013 by the American College of Surgeons Published by Elsevier Inc.
1
ISSN 1072-7515/13/$36.00 http://dx.doi.org/10.1016/j.jamcollsurg.2013.08.001
2
Rao et al
Outpatient Cholecystectomy in the Elderly
American College of Surgeons.9 The American College of Surgeons NSQIP database provides prospective, risk-adjusted, peer-controlled, and validated information from approximately 250 hospitals.10 Most of the hospitals included in NSQIP are large academic centers and community hospitals, although several hospitals of 50 beds have recently joined. The NSQIP includes all major procedures as determined by CPT codes. Patient demographics, preoperative risk factors, operative information, and 30-day postoperative outcomes are collected on randomly assigned patients at participating hospitals. Onsite audit programs standardize data collection to ensure data reliability.10-12 Morbidity and mortality outcomes within 30 days are included and are obtained if the adverse event occurred during hospitalization, after discharge, or from readmission to another hospital. Surgical clinical reviewers determine mortality through inspection of medical records, attempts to contact patients a minimum of 6 times by telephone or mail, and queries of the Social Security Death Index and the National Obituary Archives. Patient selection The database was searched for all LC cases using CPT codes 47562 and 47563. Inclusion criteria included patients at least 65 years of age. Open or partial cholecystectomies and emergency operations were excluded from the data. We identified 15,248 patients from this dataset who were at least 65 years of age and underwent elective LC. The NSQIP contains a variable specifically for ambulatory status defined as either inpatient or outpatient. This is based on the individual hospital’s definition of ambulatory status. We used this variable to separate ambulatory from nonambulatory cases. Statistical analysis Differences in baseline risk factors, comorbidities, and outcomes were analyzed by comparing the 7,499 ambulatory and 7,799 nonambulatory LC cases. The primary postoperative result of interest was 30-day mortality. Secondary outcomes of interest were 30-day morbidity, including postoperative stroke, cardiac arrest, myocardial infarction, deep vein thrombosis, pulmonary embolism, transfusion of packed red blood cells, sepsis, urinary tract infection, acute renal failure, surgical site infection, pneumonia, wound disruption, unplanned reintubation, and return to operating room. Comorbidities included hypertension, disseminated cancer of any type, alcohol abuse (more than 2 drinks per day for 2 weeks before admission), current smoker (within the last year), diabetes, on dialysis, COPD, peripheral vascular disease (history of revascularization
J Am Coll Surg
or amputation), bleeding disorder, congestive heart failure, previous cardiac surgery, earlier myocardial infarction (within 6 months), earlier stroke, or previous chemotherapy or radiotherapy (within 30 and 90 days, respectively). Body mass index and American Society of Anesthesiologists class were also included for patient characteristics. To analyze risk factors and postoperative outcomes for the ambulatory and nonambulatory group, univariate analysis was performed, using Pearson’s chi-square and Fisher’s exact test for categorical variables and Student’s t-test for continuous variables. To identify independent predictors of inpatient stay, multivariate analysis was performed using binary logistic regression using patient demographics and comorbidities as covariates and length of stay 1 day as the dependent variable. All other comorbid conditions were controlled for during this analysis. To identify independent predictors of mortality, the same multivariate analysis was done except that the dependent variable was mortality. The concordance statistics for these models were found to be 0.73 and 0.75 for inpatient stay and mortality, respectively. Multivariate results were calculated as odds ratios (OR) with 95% CIs. A p value <0.05 was considered to be statistically significant. All analyses were performed with SPSS for Mac, Version 21 (IBM Corporation).
RESULTS Of the 15,248 patients who were at least 65 years of age that underwent elective LC, 7,499 (48.9%) were ambulatory procedures and 7,799 (51.1%) were nonambulatory. Mean age of patients undergoing elective LC was 74 years and 59.9% of patients were female (Table 1). The patients undergoing ambulatory procedures were younger and had a higher proportion of females. There were no large differences in the racial demographics of the patient groups. We examined the prevalence of specific comorbidities for both groups (Table 2). Statistically significant differences were seen for hypertension (68.4% vs 75.1%; p < 0.001), diabetes (19.2% vs 23.7%; p < 0.001), COPD (5.6% vs 8.9%; p < 0.001), and congestive heart failure (0.2% vs 2.5%; p < 0.001) for ambulatory and nonambulatory cases, respectively. Only smoking status and previous radiotherapy were not significantly different. Postoperative complications include mortality (0.2% vs 1.5%; p < 0.001), stroke (0.1% vs 0.3%; p < 0.001), myocardial infarction (0.1% vs 0.6%; p < 0.001), pulmonary embolism (0.1% vs 0.3%; p ¼ 0.005), and return to operating room (0.8% vs 2.4%; p < 0.001) for ambulatory and nonambulatory cases, respectively
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Patient Demographics
Variable
Age (y), mean (SD) Female sex, % Race White, % Black, % Hispanic, % Asian, % Native American, % Other, %
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
74.1 (6.9) 59.9 d 80.7 6.5 4.5 0.6 0.6 7.1
75.6 (7.1) 56.0 d 79.3 7.7 4.7 0.9 0.6 6.8
72.6 (6.2) 63.9 d 82.1 5.1 4.4 0.4 0.6 7.4
<0.001 <0.001 d d d d d d d
(Table 3). A significantly higher rate of postoperative complications in the nonambulatory group was detected, except for the incidence of deep incisional surgical site infection. Mean operative time was also significantly shorter for the ambulatory group. To identify independent predictors of inpatient stay and mortality, multivariate analysis was performed (Tables 4 and 5), examining all comorbidities listed in Table 1. The most significant predictors of inpatient stay were dialysis (OR ¼ 2.15; 95% CI, 1.46e3.17), bleeding disorder (OR ¼ 2.89; 95% CI, 2.46e3.41), American Society of Anesthesiologists class 4 (OR ¼ 2.96; 95% CI, 1.12e7.80), and congestive heart failure Table 2.
Outpatient Cholecystectomy in the Elderly
(OR ¼ 6.95; 95% CI, 4.04e11.94). These same risk factors also independently predicted mortality.
DISCUSSION Ambulatory LC is widely accepted for the treatment of symptomatic gallstone disease in the United States.5,6 However, data on postoperative outcomes in the elderly population are limited, and specific risk factors that predict hospital admission for these patients are also not well known. Several studies have examined postoperative outcomes of ambulatory LC for patients of all ages,5,8,13,14 with each confirming the safety of this procedure. Other
Risk Factors for Ambulatory and Nonambulatory Groups
Variable
Mean body mass index ASA classification, mean (SD) Hypertension, % Disseminated cancer of any type, % Alcohol abuse,* % Current smoker, % Diabetes, % On dialysis, % COPD, % Peripheral vascular disease,y % Bleeding disorder, % Congestive heart failure, % Previous cardiac surgery, % Earlier MI,z % Earlier stroke, % Previous chemotherapy,x % Previous radiotherapy,k %
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
28.8 2.58 (0.61) 71.8 0.6 1.6 8.0 21.5 1.1 7.3 1.8 7.0 1.4 11.7 0.7 6.6 0.5 0.2
28.7 2.70 (0.62) 75.1 0.8 2.0 7.9 23.7 1.7 8.9 2.2 10.8 2.5 13.9 1.0 8.3 0.7 0.2
28.9 2.46 (0.58) 68.4 0.4 1.2 8.3 19.2 0.5 5.6 1.4 3.0 0.2 9.4 0.4 4.7 0.3 0.1
d <0.001 <0.001 0.004 <0.001 0.281 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 0.001 0.128
*More than 2 drinks per day for 2 weeks before admission. y Defined as history of revascularization or amputation. z Within 6 months preoperatively. x Within 30 days preoperatively. k Within 90 days preoperatively. ASA, American Society of Anesthesiologists.
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Table 3.
Intraoperative Data and Postoperative Outcomes
J Am Coll Surg
Outpatient Cholecystectomy in the Elderly
Outcomes
Intraoperative cholangiogram, % Mean operative time, min Mortality, % Postoperative stroke, % Cardiac arrest, % MI, % Deep vein thrombosis, % Pulmonary embolism, % Transfusion of packed red blood cells,* % Postoperative sepsis, % Urinary tract infection, % Acute renal failure, % Postoperative pneumonia, % Superficial SSI, % Deep incisional SSI, % Organ space SSI, % Wound disruption, % Unplanned reintubation, % Return to operating room, % Length of hospital stay, d, mean (SD)
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
28.5 68.1 0.9 0.2 0.2 0.3 0.4 0.2 0.3 0.8 1.2 0.3 0.8 0.6 0.1 0.6 0.1 0.9 1.6 2.81 (5.27)
32.7 77.7 1.5 0.3 0.3 0.6 0.4 0.3 0.6 0.7 1.7 0.4 1.3 0.8 0.1 0.9 0.2 1.6 2.4 5.11 (6.38)
24.2 58.1 0.2 0.1 0.1 0.1 0.1 0.1 0.1 0.2 0.8 0.1 0.2 0.5 0.1 0.3 0.0 0.1 0.8 0.40 (1.69)
<0.001 d <0.001 <0.001 0.004 <0.001 <0.001 0.005 <0.001 <0.001 <0.001 <0.001 <0.001 0.045 0.125 <0.001 <0.001 <0.001 <0.001 <0.001
*Intraoperative and postoperative. SSI, surgical site infection.
studies report the safety of LC in the elderly,7,6,15-20 but do not examine the safety of same-day discharge. These studies have found higher rates of morbidity and mortality in elderly patients, but concluded that surgery was safe with an overall low complication rate. The largest study was a retrospective analysis of 546,267 that examined ambulatory surgery in the elderly and found that earlier inpatient hospital admission within 6 months, invasiveness of surgery, and more advanced age increased risk of readmission and death within 7 days.7 However, the focus of that study was not limited to LC. Table 4. Stay
Significant Independent Predictors of Inpatient
Risk factors
Operative time Age COPD Previous chemotherapy* On dialysis Bleeding disorder ASA class 4 Congestive heart failure
Odds ratio
95% CI
p Value
1.02 1.08 1.54 2.10 2.36 2.79 2.96 6.81
1.02e1.03 1.07e1.08 1.31e1.80 1.14e3.90 1.47e3.80 2.30e3.38 1.12e7.80 3.31e14.00
<0.001 <0.001 <0.001 0.018 <0.001 <0.001 0.028 <0.001
Only statistically significant risk factors are included. *Within 30 days preoperatively. ASA, American Society of Anesthesiologists.
To date, this is the largest retrospective study on the postoperative outcomes of LC in the elderly population. Our study confirms previous literature about the safety of this procedure in the elderly with a low morbidity and mortality rate. Additionally, when specifically examining ambulatory cases in the elderly population, we found that postoperative complications remain low. The highest postoperative complication rate identified was return to the operating room (1.6%; p < 0.001), likely from surgical site complications, bleeding, and infection.21 Our multivariate analysis identified several risk factors that independently predicted both admission to the hospital and mortality. The strongest predictors were congestive heart failure, bleeding disorder, American Society of Anesthesiologists class 4, and need for dialysis. Based on these results, we recommend that patients with these comorbidities should be strongly considered for hospital admission. Interestingly, risk factors previously associated with an increased perioperative and postoperative complication rate for abdominal operation, including diabetes, increased body mass index, and smoking status were not found to be strong independent predictors of admission.22-24 These risk factors alone should not determine ambulatory vs inpatient admission status. Our study has several strengths, including a large sample size and large number of risk factors and postoperative
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Significant Independent Predictors of Mortality
Risk factors
Operative time Age COPD ASA class 4 Previous chemotherapy* On dialysis Bleeding disorder Congestive heart failure
Odds ratio
95% CI
p Value
1.02 1.08 1.54 1.62 2.09 2.65 2.83 6.76
1.02e1.03 1.07e1.08 1.32e1.81 1.52e1.73 1.13e3.87 1.62e4.33 2.33e3.43 3.29e13.90
<0.001 <0.001 <0.001 <0.001 0.019 <0.001 <0.001 <0.001
Only statistically significant risk factors are included. *Within 30 days preoperatively. ASA, American Society of Anesthesiologists.
outcomes reviewed. Additionally, we identified strong independent predictors of inpatient stay that can help determine admission status after LC. With a low morbidity and mortality rate in both ambulatory and nonambulatory groups, we are able to clearly indicate the safety of LCs in the elderly. Our study has several limitations. The nonambulatory group had a small but higher rate of comorbid conditions when compared with the ambulatory group. This might explain the consistently increased rate of postoperative complications in nonambulatory patients. However, these rates are low and comparable with other studies investigating the complication rates of LC in all age groups.25,26 Additionally, the data in NSQIP is risk adjusted by annual calculations of the observed-to-expected ratios. This allows us to account for selection bias in patients who underwent ambulatory procedures. Another was the inability to assess conversion rates to open cholecystectomy in our dataset. This might have altered the postoperative complication rates, although the effect is likely to be small, given the overall low incidence of conversion to open cases.27 Another limitation of NSQIP is intraoperative data aside from operative time, concomitant procedures, cardiac arrest, unplanned intubation, and myocardial infarction is not tracked. These variables could not be controlled for when determining independent predictors of mortality and admission to the hospital.
CONCLUSIONS With a low complication rate in the ambulatory group comparable with the nonambulatory group, our data indicate that ambulatory LC in patients older than 65 years of age is safe and can be performed. Older age alone should not be considered a strong indicator for hospital admission. Author Contributions Study conception and design: Chin, Divino, Nguyen Acquisition of data: Qiu
Outpatient Cholecystectomy in the Elderly
5
Analysis and interpretation of data: Rao, Polanco Drafting of manuscript: Rao, Nguyen Critical revision: Rao, Kim, Nguyen REFERENCES 1. Begos DG, Modlin IM. Laparoscopic cholecystectomy: from gimmick to gold standard. J Clin Gastroenterol 1994;19:325e330. 2. Sain AH. Laparoscopic cholecystectomy is the current “gold standard” for the treatment of gallstone disease. Ann Surg 1996;224:689e690. 3. Calland JF, Tanaka K, Foley E, et al. Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Ann Surg 2001;233:704e715. 4. Jain PK, Hayden JD, Sedman PC, et al. A prospective study of ambulatory laparoscopic cholecystectomy: training economic, and patient benefits. Surg Endosc 2005;19:1082e1085. 5. Fleisher LA, Yee K, Lillemoe KD, et al. Is outpatient laparoscopic cholecystectomy safe and cost-effective? A model to study transition of care. Anesthesiology 1999;90:1746e1755. 6. Elli M, Poliziani D, Colli F, et al. Impact of the introduction of laparoscopic cholecystectomy on the population aged 70 and over. Hepatogastroenterology 2001;48:1295e1297. 7. Fleisher LA, Pasternak LR, Herbert R, Anderson GF. Inpatient hospital admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of care. Arch Surg 2004;139:67e72. 8. Psaila J, Agrawal S, Fountain U, et al. Day-surgery laparoscopic cholecystectomy: factors influencing same-day discharge. World J Surg 2008;32:76e81. 9. Khuri SF, Daley J, Henderson W, et al. The National Veterans Administration Surgical Risk Study: risk adjustment for the comparative assessment of the quality of surgical care. J Am Coll Surg 1995;180:519e531. 10. Khuri SF, Daley J, Henderson W, et al. The Department of Veterans Affairs’ NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg 1998;228:491e507. 11. Khuri SF. The NSQIP: a new frontier in surgery. Surgery 2005;138:837e843. 12. Khuri SF, Henderson WG, Daley J, et al. The patient safety in surgery study: background, study design, and patient populations. J Am Coll Surg 2007;204:1089e1102. 13. Voitk AJ. Is outpatient cholecystectomy safe for the higher-risk elective patient? Surg Endosc 1997;11:1147e1149. 14. Voitk AJ, Ignatius S, Schouten BD, Mustard RA. Is outpatient surgery safe for the higher risk patient? J Gastrointest Surg 1998;2:156e158. 15. Kirshtein B, Bayme M, Bolotin A, et al. Laparoscopic cholecystectomy for acute cholecystitis in the elderly: is it safe? Surg Laparosc Endosc Percutan Tech 2008;18:334e339. 16. Bingener J, Richards ML, Schwesinger WH, et al. Laparoscopic cholecystectomy for elderly patients: gold standard for golden years? Arch Surg 2003;138:535e536. 17. Leardi S, De Vita F, Pietroletti R, Simi M. Cholecystectomy for gallbladder disease in elderly aged 80 years and over. Hepatogastroenterology 2009;56:303e306. 18. Tagle FM, Lavergne J, Barkin JS, Unger SW. Laparoscopic cholecystectomy in the elderly. Surg Endosc 1997;11: 636e638.
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Outpatient Cholecystectomy in the Elderly
19. Lo C, Lai E, Fan S, et al. Laparoscopic cholecystectomy for acute cholecystitis in the elderly. World J Surg 1996;20: 983e986. 20. Brunt LM, Quasebarth MA, Dunnegan DL, Soper NJ. Outcomes analysis of laparoscopic cholecystectomy in the extremely elderly. Surg Endosc 2001;15:700e705. 21. Birkmeyer JD, Hamby LS, Birkmeyer CM, et al. Is unplanned return to the operating room a useful quality indicator in general surgery? Arch Surg 2001;136:405e411. 22. Bamgbade OA, Rutter TW, Nafiu OO, Dorje P. Postoperative complications in obese and nonobese patients. World J Surg 2007;31:556e560. 23. Lindstro¨m D, Sadr Azodi I, Wladis A, et al. Effects of a perioperative smoking cessation intervention on postoperative
24. 25. 26. 27.
complications: a randomized trial. Ann Surg 2008;248: 739e745. Virkkunen J, Heikkinen M, Lepantalo M, et al. Diabetes as an independent risk factor for early postoperative complications in critical limb ischemia. J Vasc Surg 2004;40:761e767. Deziel DJ, Millikan KW, Economou SG, et al. Complications of laparoscopic cholecystectomy: a national survey of 4,292 hospitals and an analysis of 77,604 cases. Am J Surg 1993;165:9e14. Shea JA, Healey MJ, Berlin JA, et al. Mortality and complications associated with laparoscopic cholecystectomy. A metaanalysis. Ann Surg 1996;224:609e620. Livingston EH, Rege RV. A nationwide study of conversion from laparoscopic to open cholecystectomy. Am J Surg 2004;188:205e211.
MD,
Edward H Chin,
MD, FACS,
Studies have shown that laparoscopic cholecystectomy (LC) in an ambulatory setting is a safe alternative to the traditional overnight hospital stay. However, there are limited data on the morbidity and mortality of outpatient LC in elderly patients. We evaluated the safety of ambulatory LC in the elderly and identified risk factors that predict inpatient admission. STUDY DESIGN: A retrospective analysis was performed using the American College of Surgeon’s NSQIP database between 2007 and 2010. The database was searched for patients older than 65 years of age who underwent elective LC at all participating hospitals in the United States. Data from 15,248 patients were collected and we compared patients who underwent ambulatory procedures with those patients who were admitted for an inpatient stay. RESULTS: Seven thousand four hundred and ninety-nine (48.9%) patients were ambulatory and 7,799 (51.1%) were nonambulatory. Postoperative complications included mortality (0.2% vs 1.5%; p < 0.001), stroke (0.1% vs 0.3%; p < 0.001), myocardial infarction (0.1% vs 0.6%; p < 0.001), pulmonary embolism (0.1% vs 0.3%; p ¼ 0.005), and sepsis (0.2% vs 0.7%; p < 0.001) for ambulatory and nonambulatory cases, respectively. We identified significant independent predictors of inpatient admission and mortality, including congestive heart failure, American Society of Anesthesiologists class 4, bleeding disorder, and renal failure requiring dialysis. CONCLUSIONS: We believe ambulatory LCs are safe in elderly patients as demonstrated by low complication rates. We identified multiple risk factors that might warrant inpatient hospital admission. (J Am Coll Surg 2013;-:1e6. 2013 by the American College of Surgeons)
BACKGROUND:
Laparoscopic cholecystectomy (LC) is currently the accepted treatment for symptomatic gallstone disease, and remains one of the most frequently performed surgical procedures.1,2 Rapid recovery and excellent surgical outcomes have led to progressively shorter hospital stays.3 In recent years, outpatient LC has gained popularity and is now widely accepted and practiced in the United States.4 Multiple studies have demonstrated that LC in an ambulatory setting is a safe alternative to the traditional overnight hospital stay.5,6
Several studies have examined risk factors that predispose patients to a longer hospital stay after LC, with age older than 65 as a risk factor.7,8 However, there are limited data on higher postoperative complications in elderly patients who are discharged several hours after surgery compared with those who are admitted for overnight observation, and uncertainty exists on the safety of outpatient LC in the elderly. This is a 4-year retrospective study examining a large, nationwide database to investigate the postoperative complication rate in patients 65 years of age or older undergoing elective, outpatient LC.
CME questions for this article available at http://jacscme.facs.org
METHODS
Disclosure Information: Authors have nothing to disclose. Timothy J Eberlein, Editor-in-Chief, has nothing to disclose.
Data source A retrospective analysis was performed using the American College of Surgeon’s NSQIP dataset between 2007 and 2010. The NSQIP database was originally developed within the Veterans Health Administration System and was later expanded to the private sector by the
Received June 29, 2013; Revised August 1, 2013; Accepted August 1, 2013. From the Department of Surgery, Mount Sinai Medical Center, New York, NY. Correspondence address: Scott Q Nguyen, MD, Department of Surgery, Mount Sinai Medical Center, 5 E 98th St, Box 1259, New York, NY 10029. email: [email protected]
ª 2013 by the American College of Surgeons Published by Elsevier Inc.
1
ISSN 1072-7515/13/$36.00 http://dx.doi.org/10.1016/j.jamcollsurg.2013.08.001
2
Rao et al
Outpatient Cholecystectomy in the Elderly
American College of Surgeons.9 The American College of Surgeons NSQIP database provides prospective, risk-adjusted, peer-controlled, and validated information from approximately 250 hospitals.10 Most of the hospitals included in NSQIP are large academic centers and community hospitals, although several hospitals of 50 beds have recently joined. The NSQIP includes all major procedures as determined by CPT codes. Patient demographics, preoperative risk factors, operative information, and 30-day postoperative outcomes are collected on randomly assigned patients at participating hospitals. Onsite audit programs standardize data collection to ensure data reliability.10-12 Morbidity and mortality outcomes within 30 days are included and are obtained if the adverse event occurred during hospitalization, after discharge, or from readmission to another hospital. Surgical clinical reviewers determine mortality through inspection of medical records, attempts to contact patients a minimum of 6 times by telephone or mail, and queries of the Social Security Death Index and the National Obituary Archives. Patient selection The database was searched for all LC cases using CPT codes 47562 and 47563. Inclusion criteria included patients at least 65 years of age. Open or partial cholecystectomies and emergency operations were excluded from the data. We identified 15,248 patients from this dataset who were at least 65 years of age and underwent elective LC. The NSQIP contains a variable specifically for ambulatory status defined as either inpatient or outpatient. This is based on the individual hospital’s definition of ambulatory status. We used this variable to separate ambulatory from nonambulatory cases. Statistical analysis Differences in baseline risk factors, comorbidities, and outcomes were analyzed by comparing the 7,499 ambulatory and 7,799 nonambulatory LC cases. The primary postoperative result of interest was 30-day mortality. Secondary outcomes of interest were 30-day morbidity, including postoperative stroke, cardiac arrest, myocardial infarction, deep vein thrombosis, pulmonary embolism, transfusion of packed red blood cells, sepsis, urinary tract infection, acute renal failure, surgical site infection, pneumonia, wound disruption, unplanned reintubation, and return to operating room. Comorbidities included hypertension, disseminated cancer of any type, alcohol abuse (more than 2 drinks per day for 2 weeks before admission), current smoker (within the last year), diabetes, on dialysis, COPD, peripheral vascular disease (history of revascularization
J Am Coll Surg
or amputation), bleeding disorder, congestive heart failure, previous cardiac surgery, earlier myocardial infarction (within 6 months), earlier stroke, or previous chemotherapy or radiotherapy (within 30 and 90 days, respectively). Body mass index and American Society of Anesthesiologists class were also included for patient characteristics. To analyze risk factors and postoperative outcomes for the ambulatory and nonambulatory group, univariate analysis was performed, using Pearson’s chi-square and Fisher’s exact test for categorical variables and Student’s t-test for continuous variables. To identify independent predictors of inpatient stay, multivariate analysis was performed using binary logistic regression using patient demographics and comorbidities as covariates and length of stay 1 day as the dependent variable. All other comorbid conditions were controlled for during this analysis. To identify independent predictors of mortality, the same multivariate analysis was done except that the dependent variable was mortality. The concordance statistics for these models were found to be 0.73 and 0.75 for inpatient stay and mortality, respectively. Multivariate results were calculated as odds ratios (OR) with 95% CIs. A p value <0.05 was considered to be statistically significant. All analyses were performed with SPSS for Mac, Version 21 (IBM Corporation).
RESULTS Of the 15,248 patients who were at least 65 years of age that underwent elective LC, 7,499 (48.9%) were ambulatory procedures and 7,799 (51.1%) were nonambulatory. Mean age of patients undergoing elective LC was 74 years and 59.9% of patients were female (Table 1). The patients undergoing ambulatory procedures were younger and had a higher proportion of females. There were no large differences in the racial demographics of the patient groups. We examined the prevalence of specific comorbidities for both groups (Table 2). Statistically significant differences were seen for hypertension (68.4% vs 75.1%; p < 0.001), diabetes (19.2% vs 23.7%; p < 0.001), COPD (5.6% vs 8.9%; p < 0.001), and congestive heart failure (0.2% vs 2.5%; p < 0.001) for ambulatory and nonambulatory cases, respectively. Only smoking status and previous radiotherapy were not significantly different. Postoperative complications include mortality (0.2% vs 1.5%; p < 0.001), stroke (0.1% vs 0.3%; p < 0.001), myocardial infarction (0.1% vs 0.6%; p < 0.001), pulmonary embolism (0.1% vs 0.3%; p ¼ 0.005), and return to operating room (0.8% vs 2.4%; p < 0.001) for ambulatory and nonambulatory cases, respectively
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Patient Demographics
Variable
Age (y), mean (SD) Female sex, % Race White, % Black, % Hispanic, % Asian, % Native American, % Other, %
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
74.1 (6.9) 59.9 d 80.7 6.5 4.5 0.6 0.6 7.1
75.6 (7.1) 56.0 d 79.3 7.7 4.7 0.9 0.6 6.8
72.6 (6.2) 63.9 d 82.1 5.1 4.4 0.4 0.6 7.4
<0.001 <0.001 d d d d d d d
(Table 3). A significantly higher rate of postoperative complications in the nonambulatory group was detected, except for the incidence of deep incisional surgical site infection. Mean operative time was also significantly shorter for the ambulatory group. To identify independent predictors of inpatient stay and mortality, multivariate analysis was performed (Tables 4 and 5), examining all comorbidities listed in Table 1. The most significant predictors of inpatient stay were dialysis (OR ¼ 2.15; 95% CI, 1.46e3.17), bleeding disorder (OR ¼ 2.89; 95% CI, 2.46e3.41), American Society of Anesthesiologists class 4 (OR ¼ 2.96; 95% CI, 1.12e7.80), and congestive heart failure Table 2.
Outpatient Cholecystectomy in the Elderly
(OR ¼ 6.95; 95% CI, 4.04e11.94). These same risk factors also independently predicted mortality.
DISCUSSION Ambulatory LC is widely accepted for the treatment of symptomatic gallstone disease in the United States.5,6 However, data on postoperative outcomes in the elderly population are limited, and specific risk factors that predict hospital admission for these patients are also not well known. Several studies have examined postoperative outcomes of ambulatory LC for patients of all ages,5,8,13,14 with each confirming the safety of this procedure. Other
Risk Factors for Ambulatory and Nonambulatory Groups
Variable
Mean body mass index ASA classification, mean (SD) Hypertension, % Disseminated cancer of any type, % Alcohol abuse,* % Current smoker, % Diabetes, % On dialysis, % COPD, % Peripheral vascular disease,y % Bleeding disorder, % Congestive heart failure, % Previous cardiac surgery, % Earlier MI,z % Earlier stroke, % Previous chemotherapy,x % Previous radiotherapy,k %
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
28.8 2.58 (0.61) 71.8 0.6 1.6 8.0 21.5 1.1 7.3 1.8 7.0 1.4 11.7 0.7 6.6 0.5 0.2
28.7 2.70 (0.62) 75.1 0.8 2.0 7.9 23.7 1.7 8.9 2.2 10.8 2.5 13.9 1.0 8.3 0.7 0.2
28.9 2.46 (0.58) 68.4 0.4 1.2 8.3 19.2 0.5 5.6 1.4 3.0 0.2 9.4 0.4 4.7 0.3 0.1
d <0.001 <0.001 0.004 <0.001 0.281 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 0.001 0.128
*More than 2 drinks per day for 2 weeks before admission. y Defined as history of revascularization or amputation. z Within 6 months preoperatively. x Within 30 days preoperatively. k Within 90 days preoperatively. ASA, American Society of Anesthesiologists.
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Table 3.
Intraoperative Data and Postoperative Outcomes
J Am Coll Surg
Outpatient Cholecystectomy in the Elderly
Outcomes
Intraoperative cholangiogram, % Mean operative time, min Mortality, % Postoperative stroke, % Cardiac arrest, % MI, % Deep vein thrombosis, % Pulmonary embolism, % Transfusion of packed red blood cells,* % Postoperative sepsis, % Urinary tract infection, % Acute renal failure, % Postoperative pneumonia, % Superficial SSI, % Deep incisional SSI, % Organ space SSI, % Wound disruption, % Unplanned reintubation, % Return to operating room, % Length of hospital stay, d, mean (SD)
All patients (N ¼ 15,248)
Nonambulatory (n ¼ 7,799 [51.1%])
Ambulatory (n ¼ 7,499 [48.9%])
p Value
28.5 68.1 0.9 0.2 0.2 0.3 0.4 0.2 0.3 0.8 1.2 0.3 0.8 0.6 0.1 0.6 0.1 0.9 1.6 2.81 (5.27)
32.7 77.7 1.5 0.3 0.3 0.6 0.4 0.3 0.6 0.7 1.7 0.4 1.3 0.8 0.1 0.9 0.2 1.6 2.4 5.11 (6.38)
24.2 58.1 0.2 0.1 0.1 0.1 0.1 0.1 0.1 0.2 0.8 0.1 0.2 0.5 0.1 0.3 0.0 0.1 0.8 0.40 (1.69)
<0.001 d <0.001 <0.001 0.004 <0.001 <0.001 0.005 <0.001 <0.001 <0.001 <0.001 <0.001 0.045 0.125 <0.001 <0.001 <0.001 <0.001 <0.001
*Intraoperative and postoperative. SSI, surgical site infection.
studies report the safety of LC in the elderly,7,6,15-20 but do not examine the safety of same-day discharge. These studies have found higher rates of morbidity and mortality in elderly patients, but concluded that surgery was safe with an overall low complication rate. The largest study was a retrospective analysis of 546,267 that examined ambulatory surgery in the elderly and found that earlier inpatient hospital admission within 6 months, invasiveness of surgery, and more advanced age increased risk of readmission and death within 7 days.7 However, the focus of that study was not limited to LC. Table 4. Stay
Significant Independent Predictors of Inpatient
Risk factors
Operative time Age COPD Previous chemotherapy* On dialysis Bleeding disorder ASA class 4 Congestive heart failure
Odds ratio
95% CI
p Value
1.02 1.08 1.54 2.10 2.36 2.79 2.96 6.81
1.02e1.03 1.07e1.08 1.31e1.80 1.14e3.90 1.47e3.80 2.30e3.38 1.12e7.80 3.31e14.00
<0.001 <0.001 <0.001 0.018 <0.001 <0.001 0.028 <0.001
Only statistically significant risk factors are included. *Within 30 days preoperatively. ASA, American Society of Anesthesiologists.
To date, this is the largest retrospective study on the postoperative outcomes of LC in the elderly population. Our study confirms previous literature about the safety of this procedure in the elderly with a low morbidity and mortality rate. Additionally, when specifically examining ambulatory cases in the elderly population, we found that postoperative complications remain low. The highest postoperative complication rate identified was return to the operating room (1.6%; p < 0.001), likely from surgical site complications, bleeding, and infection.21 Our multivariate analysis identified several risk factors that independently predicted both admission to the hospital and mortality. The strongest predictors were congestive heart failure, bleeding disorder, American Society of Anesthesiologists class 4, and need for dialysis. Based on these results, we recommend that patients with these comorbidities should be strongly considered for hospital admission. Interestingly, risk factors previously associated with an increased perioperative and postoperative complication rate for abdominal operation, including diabetes, increased body mass index, and smoking status were not found to be strong independent predictors of admission.22-24 These risk factors alone should not determine ambulatory vs inpatient admission status. Our study has several strengths, including a large sample size and large number of risk factors and postoperative
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Table 5.
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Rao et al
2013
Significant Independent Predictors of Mortality
Risk factors
Operative time Age COPD ASA class 4 Previous chemotherapy* On dialysis Bleeding disorder Congestive heart failure
Odds ratio
95% CI
p Value
1.02 1.08 1.54 1.62 2.09 2.65 2.83 6.76
1.02e1.03 1.07e1.08 1.32e1.81 1.52e1.73 1.13e3.87 1.62e4.33 2.33e3.43 3.29e13.90
<0.001 <0.001 <0.001 <0.001 0.019 <0.001 <0.001 <0.001
Only statistically significant risk factors are included. *Within 30 days preoperatively. ASA, American Society of Anesthesiologists.
outcomes reviewed. Additionally, we identified strong independent predictors of inpatient stay that can help determine admission status after LC. With a low morbidity and mortality rate in both ambulatory and nonambulatory groups, we are able to clearly indicate the safety of LCs in the elderly. Our study has several limitations. The nonambulatory group had a small but higher rate of comorbid conditions when compared with the ambulatory group. This might explain the consistently increased rate of postoperative complications in nonambulatory patients. However, these rates are low and comparable with other studies investigating the complication rates of LC in all age groups.25,26 Additionally, the data in NSQIP is risk adjusted by annual calculations of the observed-to-expected ratios. This allows us to account for selection bias in patients who underwent ambulatory procedures. Another was the inability to assess conversion rates to open cholecystectomy in our dataset. This might have altered the postoperative complication rates, although the effect is likely to be small, given the overall low incidence of conversion to open cases.27 Another limitation of NSQIP is intraoperative data aside from operative time, concomitant procedures, cardiac arrest, unplanned intubation, and myocardial infarction is not tracked. These variables could not be controlled for when determining independent predictors of mortality and admission to the hospital.
CONCLUSIONS With a low complication rate in the ambulatory group comparable with the nonambulatory group, our data indicate that ambulatory LC in patients older than 65 years of age is safe and can be performed. Older age alone should not be considered a strong indicator for hospital admission. Author Contributions Study conception and design: Chin, Divino, Nguyen Acquisition of data: Qiu
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5
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