Author's Accepted Manuscript 30-day hospital readmission after robotic partial nephrectomy, are we prepared for Medicare Readmission Reduction Program? Luis Felipe Brandao, Homayoun Zargar, Humberto Laydner, Oktay Akca, Riccardo Autorino, Oliver Ko, Dinesh Samarasekera, Jianbo Li, John Rabets, Jayram Krishnan, Georges-Pascal Haber, Jihad Kaouk, Robert Stein PII: DOI: Reference:
S0022-5347(14)00260-2 10.1016/j.juro.2014.02.009 JURO 11096
To appear in: The Journal of Urology Accepted Date: 7 February 2014 Please cite this article as: Brandao LF, Zargar H, Laydner H, Akca O, Autorino R, Ko O, Samarasekera D, Li J, Rabets J, Krishnan J, Haber GP, Kaouk J, Stein R, 30-day hospital readmission after robotic partial nephrectomy, are we prepared for Medicare Readmission Reduction Program?, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.02.009. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT 30-day hospital readmission after robotic partial nephrectomy, are we prepared for Medicare Readmission Reduction Program? Luis Felipe Brandao1, Homayoun Zargar1, Humberto Laydner1, Oktay Akca1, Riccardo Autorino1, Oliver Ko2, Dinesh Samarasekera1, Jianbo Li3, John Rabets1,
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Jayram Krishnan1, Georges-Pascal Haber1, Jihad Kaouk1, Robert Stein1
1- Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
SC
2- Case Western Reserve University School of Medicine, Cleveland, Ohio
3- Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland,
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OH, USA.
Robert J. Stein, M.D.,
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Corresponding author:
EP
9500 Euclid Avenue, Glickman Urology and Kidney Institute / Q10-1, Cleveland Clinic. Cleveland, OH, 44195, United States; Tel. +1 216 445-4800; Fax: +1 216 445-2267;
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E-mail: [email protected]
1
ACCEPTED MANUSCRIPT ABSTRACT
INTRODUCTION: After the Centers for Medicare and Medicaid Services introduced the concept of Hospital Readmission Reduction Program, hospitals and health care centers are financially penalized for exceeding specific readmission rates. AND
METHODS:
We
retrospectively
reviewed
our
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MATERIALS
institutional review board approved database of patients undergoing robotic partial nephrectomy (RPN) at our institution and included patients who were readmitted to any hospital as an inpatient stay within 30 days from discharge after RPN.
SC
RESULTS: From March 2006 to March 2013, 627 patients underwent RPN at our center. Twenty eight (4.46%) patients were readmitted within 30 days of surgery. Postoperative bleeding was responsible for 8 (28.5%) readmissions. Pulmonary
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embolism was reported in 3 cases and retroperitoneal abscess was diagnosed in 2 patients. Two patients developed urinary leak requiring surgical intervention. Pneumonia was diagnosed in two cases. Two patients were readmitted for chest pain. Overall 9 (32.1%) patients presented with major complications requiring any intervention. On multivariable analysis, Charlson score was the only factor
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significantly associated with a higher 30-day readmission rate (p=0.03). If the Charlson score was ≥ 5, the chance for readmission would be 2.7 times higher. CONCLUSION: Increased comorbidities, specifically Charlson comorbidity index ≥ 5, was the only significant predictor of higher incidence of 30-day
EP
readmission. This information can be useful when counseling patients for RPN procedure and also for determining baseline rates if CMS expand the number of
AC C
conditions they evaluate for excess 30-day readmissions.
2
ACCEPTED MANUSCRIPT INTRODUCTION In October 1st of 2012, the Centers for Medicare and Medicaid Services (CMS) introduced the concept of Hospital Readmission Reduction Program (HRRP). Based on this, hospitals and health care centers are financially penalized for
RI PT
exceeding specific readmission rates. CMS established a methodology to calculate the excess readmission ratio for each applicable condition, which is used, in part, to calculate the readmission payment adjustment. Currently, only the 3 diagnoses of myocardial infarction, congestive heart failure and pneumonia (with clinical
SC
adjustment factors such as comorbidities, patient frailty and demographics) are used as readmission measures for calculating excess readmission ratios. However, there is a plan for expanding the conditions subject to penalty in financial year 2015 1. A
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recent analysis of Medicare claims data found that 15% of readmissions after primarily surgical care were within 30 days after the discharge 2. Among the readmitted surgical patients 72.6% were hospitalized for medical diagnoses. The study estimated that in 2004 the cost for unplanned rehospitalization for medicare was US$17.4 billion. Beyond financial considerations, the process of readmission affects
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the patients’ overall health journey negatively 3.
There is a paucity of data with regards to 30-day readmission after urological surgery. Given the widespread use of minimally invasive surgery and more recently robotic assisted laparoscopic surgery, it would be of interest to assess the 30-day
EP
readmission rates after such procedures. Herein, we review our robotic partial nephrectomy (RPN) 30-day readmission rate and evaluate the prevalence of factors
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which it may be associated with.
PATIENTS AND METHODS
Patients and data:
We retrospectively reviewed our institutional review board (IRB) approved database of patients undergoing RPN at our center. We included patients who were readmitted to any hospital as an inpatient stay within 30 days from discharge after RPN. Patients were cross-referenced with our electronic medical records for accuracy of the post-operative complications and readmissions. In the case of readmission to another hospital, medical records were obtained and examined. We collected data on 3
ACCEPTED MANUSCRIPT patients’ demographics, tumor characteristics and perioperative events. The demographic parameters assessed were age, gender, race, body mass index, side of tumor, A.S.A. score (American Society of Anesthesiologists), Charlson comorbidity index 4, R.E.N.A.L. nephrometry score
5
and preoperative estimated glomerular
filtration rate (eGFR). The eGFR was calculated by using modification of diet in renal
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disease (MDRD) formula 6. Chronic kidney disease was defined as an eGFR 2 g/dL, gross hematuria or any clinically overt sign of hemorrhage, regardless whether it required any intervention or not. Urinary leak was defined as persistent drain output more than 48h after the procedure and with drained fluid analysis consistent with urine. Ileus was defined as inability to tolerate a regular diet after 4 days from the
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procedure 8.
Patients were divided in 2 groups (readmitted and non-readmitted) and comparisons between them were made using Wilcoxon rank-sum test for continuous
EP
variables, and chi-squared test for categorical variables. Multivariable logistic regression analysis was applied to identify factors associated with readmission.
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Statistical software R (version 3) and its Regression Modeling Strategies package were used. Results were considered significant when p value was < 0.05.
Surgical technique, post-operative care and discharge: Our surgical technique has been described in detail previously 9. The postoperative care is based on our institutional care pathway, but may have slight variations according to each surgeon’s preference. Intravenous fluids, analgesics, 24 hours of antibiotics, and prophylaxis for deep vein thrombosis usually in the form of knee-high sequential compression stockings were administrated to patients. Hemoglobin levels and hematocrit are monitored daily during the postoperative 4
ACCEPTED MANUSCRIPT period. The Foley catheter and drain are usually removed on the morning after surgery; ambulation is encouraged, and the diet is advanced. Patients are discharged after passage of flatus, tolerating a regular diet, mobilizing and with pain managed with oral medications. Discharge destination was determined on an individual basis and need for in-patient rehabilitation was uncommon. At the time of discharge,
RI PT
patients have a scheduled follow-up appointment within 7-10 days from the surgery. Patients are provided with advice, contact numbers and instructions in the events of any concerns or complications. In the events of complications after hours, patients are assessed by an emergency/family physician and decision for readmission is made
SC
after discussion with the primary urology physician.
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RESULTS
From March 2006 to March 2013, 627 patients underwent RPN at our center. Table 1 shows patient characteristics and operative data. Twenty eight (4.46%) patients were readmitted within 30 days of surgery. The causes for 30-day readmissions, divided according to their respective Charlson cormobidity index and
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body system, and categorized by Clavien grading and interventions (if any) for the complications are outlined in Table 2. The percentages of each Clavien grade are shown in table 3. Median (range) postoperative day of readmission was day 9 (3 – 26)
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and the median (range) length of stay during the readmission was 3 days (1 – 15).
Urological complications:
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Bleeding: Postoperative bleeding presenting as gross hematuria was responsible for 8 (28.5%) readmissions. Seven patients required blood transfusion, including one who required open radical nephrectomy secondary to hemodynamic instability, one was taken to the OR for clot evacuation, four were treated with angioembolization, and one did not require any additional procedures. This patient was observed for 24 hours and discharged with no need for transfusion or any other treatment. Only one patient needed stay in Intensive Care Unit (3 days). Infection: Retroperitoneal abscess was diagnosed in 2 patients. While one patient had a small abscess that was treated conservatively, the second patient presented with a 6.6 cm abscess requiring percutaneous drainage under CT guidance. One patient developed superficial wound infection and another patient developed 5
ACCEPTED MANUSCRIPT pyelonephritis. Both of them resolved after antibiotic therapy. Urine Leak: Two patients developed urinary leak requiring surgical intervention. One was treated with nephrostomy tube insertion and percutaneous drainage. The other patient was treated with retrograde stent insertion. Both patients had spontaneous resolution of their urinary fistulae without the need for further
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procedures.
Non-urological complications:
Thrombo-embolic events: Pulmonary embolism was reported in 3 cases.
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Prompt anticoagulation was performed in all of them. One patient was diagnosed with deep venous thrombosis. He was treated with anticoagulation and discharged after 3 days.
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Infection: Pneumonia was diagnosed in two patients and both were readmitted within the first 10 days after surgery. They were treated with empiric antibiotics and discharged after 4 days.
Cardiac: Two patients were readmitted complaining of chest pain and cardiac evaluation was negative for both patients.
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Minor causes of readmission were promptly diagnosed and treated conservatively such as, gout flare, abdominal pain, ileus and diarrhea. Overall 9 (32.1%) patients presented with major complications requiring intervention. Five (17.8%) of them were treated with sedation and local anesthesia,
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while 3 (two Clavien 3b and one Clavien 4a) required treatment under general anesthesia. One patient required intensive care Unit for hemodynamics control. No
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deaths occurred within 30 days after surgery. Table 3 shows the percentage of each Clavien grade in the readmitted population.
Comparison between the two cohorts: Patients who were readmitted had significantly higher Charlson comorbidity
score (5.8 ± 1.6 vs 5.1 ± 1.8; p=0.02). There were no significant differences between the non-readmitted and the readmitted groups, in terms of age (58.3 ± 12.3 vs 58.6 ± 14.1; p= 0.94), BMI (30.5 ± 7.0 vs 31.6 ± 6.8; p= 0.28), tumor size (3.2 ± 1.6 vs 3.1 ± 1.5; p= 0.7), R.E.N.A.L median (range) nephrometry score (7 (4 – 12) vs 6 (4 – 11); p= 0.71), Operative time (181.9 ± 53.7 vs 191.3 ± 41.2; p= 0.24), mean EBL (239.9 ± 256 vs 193 ± 135.2; p=0.63), mean LOS (3.4 ± 1.7 vs 4.0 ± 2.4; p=0.13) and mean 6
ACCEPTED MANUSCRIPT WIT (21.4 ± 8.7 vs 21.5 ± 6.2; p= 0.58). Comparing the preoperative and postoperative incidence of CKD (eGFR < 60 ml/min/1.73m2), we observed no difference between non-readmitted and readmitted groups (15.1% vs 20.7%, and 15.9% vs 20%; p=0.57 and p=0.86, respectively). On univariable analysis, these were not associated with an increased risk of readmission
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(p=0.41 and p=0.63 for preoperative and postoperative CKD respectively).
Factors predicting readmission:
On univariable analysis, Charlson Comorbidity Score was found to be
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significantly associated with readmission rate (p=0.03). Length of stay and race (African-American) trended for higher readmission, but did not reach significance (p=0.09 and 0.07, respectively).
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On multivariable analysis, Charlson score was the only factor significantly associated with a higher 30-day readmission rate. If the Charlson score was ≥ 5, the chance for readmission would be 2.77 times higher (CI 95% = 1.10 – 6.94; p=0.03). LOS trended to increasing the likelihood of readmission (p=0.08). Univariable and
DISCUSSION
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multivariable analyses are shown in table 4.
The concept of 30-day readmission rate after surgical procedures is not new.
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However, this data is not consistently reported. Commonly used surgical complication grading systems 7,10 do not include hospital readmission as a specific criteria, to grade
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complications. Also, because readmission can take place in a different facility from where the index admission occurred, the true incidence is potentially underestimated. The Affordable Care Act of 201011 requires the U.S. Department of Health & Human Services (HHS) to establish a readmission reduction program. This program, effective since October 1, 2012, is intended to provide incentives for hospitals to implement strategies to reduce the number of costly and unnecessary hospital readmissions. This is likely to lead to better documentation and enhanced reporting of such data in the literature. It is important to report the specialty and procedure specific data and to analyze their variations, in order to identify factors associated with higher 30-day readmission and formulate prevention strategies.
7
ACCEPTED MANUSCRIPT A recent study reported the 30-day readmission after robotic radical prostatectomy
12
. On review of over 100 manuscripts published on the subject of
robotic partial nephrectomy (RPN) in 2013, we identified only 4 that reported the readmission rate in the results section
13-16
. To our knowledge, this study is the first
one focusing on the 30-day readmission after robotic partial nephrectomy (RPN) and
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assessing the factors contributing to it. In our series the rate of 30-day readmission was 4.4 % for all causes. The reported 30-day readmission rate for RPN in published literature ranges from 0 to 8%, as shown in Table 5. The reported rate of 30-day readmission for robotic prostatectomy is 3.5%12 and for robotic radical cystectomy is within reported range of
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18-28%17,18. Thirty-day readmission rate in our present series is lower than the reported readmission rates for other nephron sparing surgical modalities. In a
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cohort of 2321 patients, Tan and colleagues reported, 30-day re-hospitalization rates of 9.7 and 9% for laparoscopic and open partial nephrectomy, respectively 19
. Nogueira et al presented a readmission rate of 10.4% for laparoscopic partial
nephrectomy in a single center series of 144 patients
20
. Direct comparison
between these studies given the differences in patient demographics, characteristics of
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the specific pathology, and difference in procedures is not possible; however it provides a framework for overall comparison when contemplating morbidity of each procedure. This data can also be utilized when counseling patients for RPN. As already mentioned, readmission can take place in a different facility from where
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the index admission occurred, which can translate into an underestimation of the true incidence. This issue has been overcome in our study by obtaining and
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recording events occurring in other hospitals. Among the studies included in Table 5, only Abaza et al addressed this issue by assessing and recording ED visits and readmissions to other hospitals based on self-reporting by patients15. On multivariable analysis, higher patient comorbidity index was the only
predictor of increased 30-day readmission in our cohort. None of the traditional factors predicting complications, i.e. BMI duration of surgery
12
21
, R.E.N.A.L nephrometry score
22,23
or
were associated with a difference in readmission rate. With an
aging population and improvements in medical technology, we may be offering nephron sparing surgery to an older population with more medical co-morbidities. Patients with more co-morbidities are more likely to have postoperative complications 24
and as shown in this study have a higher incidence of 30-day readmission. 8
ACCEPTED MANUSCRIPT An additional consideration is that referral centers may tend to receive more complex patients than other hospitals. Based on reports such as this, CMS could consider using a correction factor according to the comorbidity of the population treated in each institution. An undesired effect otherwise may be hospitals attempting to create mechanisms to restrict the first admission of patients with more comorbid
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conditions or indicated readmission, in efforts to avoid Medicare reimbursement cuts. Use of retrospective data from a single institution is the main limitation of this study. Given the high volume nature of our RPN practice, these results might not be applicable to other settings. To our knowledge, this is the first study specifically
SC
reporting on the 30-day readmission after RPN.
Conclusion:
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The 30-day readmission rate after robotic partial nephrectomy in our series was 4.4%. Increased comorbidities, specifically Charlson comorbidity index of ≥ 5, was the only significant predictor of higher incidence of 30-day readmission. This information can be used when counseling patients for RPN procedure. Studies such as these may also be used to determine reference readmission rates if CMS plans to
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REFERENCES:
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expand the number of conditions they evaluate for excess 30-day readmissions.
1. (Accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
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Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html. Accessed on November 30th, 2013)
2. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009;360:1418-28.
3. Hinami K, Bilimoria KY, Kallas PG, Simons YM, Christensen NP, Williams MV. Patient experiences after hospitalizations for elective surgery. Am J Surg 2013. 4. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. Journal of chronic diseases 1987;40:373-83.
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ACCEPTED MANUSCRIPT 5. Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol 2009;182:844-53. 6. Levey AS, Coresh J, Greene T, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for
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estimating glomerular filtration rate. Ann Intern Med 2006;145:247-54. 7. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13.
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8. Vather R, Trivedi S, Bissett I et al Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg, 2013 May;17(5):962-72
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9. Kaouk JH, Khalifeh A, Hillyer S, Haber GP, Stein RJ, Autorino R. Robotassisted laparoscopic partial nephrectomy: step-by-step contemporary technique and surgical outcomes at a single high-volume institution. Eur Urol 2012;62:553-61.
10. Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in
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reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol 2013;190:1271-4. 11. Patient Protection and Affordable Care Act. . Pub L No 111-148. 12. Pilecki MA, McGuire BB, Jain UK, Kim J, Nadler RB. National multi-
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institutional comparison of 30-day post-operative complication and readmission rates between open retropubic radical prostatectomy (RRP)
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and robot-assisted laparoscopic prostatectomy (RALRP) using NSQIP. J Endourol 2013.
13. Khalifeh A, Autorino R, Hillyer SP, et al. Comparative outcomes and assessment of trifecta in 500 robotic and laparoscopic partial nephrectomy cases: a single surgeon experience. J Urol 2013;189:123642. 14. Patel A, Golan S, Razmaria A, Prasad S, Eggener S, Shalhav A. Early discharge after laparoscopic or robotic partial nephrectomy: care pathway evaluation. BJU Int 2013.
10
ACCEPTED MANUSCRIPT 15. Abaza R, Shah K. A single overnight stay is possible for most patients undergoing robotic partial nephrectomy. Urology 2013;81:301-6. 16. Alemozaffar M, Chang SL, Kacker R, Sun M, DeWolf WC, Wagner AA. Comparing costs of robotic, laparoscopic, and open partial nephrectomy. J Endourol 2013;27:560-5.
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17. Styn NR, Montgomery JS, Wood DP, et al. Matched comparison of roboticassisted and open radical cystectomy. Urology 2012;79:1303-8.
18. Kader AK, Richards KA, Krane LS, Pettus JA, Smith JJ, Hemal AK. Robotassisted laparoscopic vs open radical cystectomy: comparison of
SC
complications and perioperative oncological outcomes in 200 patients. BJU Int 2013;112:E290-4.
19. Tan HJ, Wolf JS, Miller DC et al. Population-level assessment of the
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hospital-based outcomes following laparoscopic versus open partial nephrectomy during the adoption of minimally-invasive surgery. J Urol. 2013; Nov 7 (Epub ahead of print)
20. Nogueira L, Katz Darren, Coleman JA, et al. Critical Evaluation of perioperative complications in laparoscopic partial nephrectomy.
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Urology. 2010;75:288-294.
21. Amri R, Bordeianou LG, Sylla P, Berger DL. Obesity, outcomes and quality of care: body mass index increases the risk of wound-related complications in colon cancer surgery. Am J Surg 2013.
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22. Simhan J, Smaldone MC, Tsai KJ, et al. Objective measures of renal mass anatomic complexity predict rates of major complications following
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partial nephrectomy. Eur Urol 2011;60:724-30.
23. Liu ZW, Olweny EO, Yin G, et al. Prediction of perioperative outcomes following minimally invasive partial nephrectomy: role of the R.E.N.A.L nephrometry score. World journal of urology 2013;31:1183-9.
24. Revenig LM, Canter DJ, Taylor MD, et al. Too frail for surgery? Initial results of a large multidisciplinary prospective study examining preoperative variables predictive of poor surgical outcomes. Journal of the American College of Surgeons 2013;217:665-70 e1.
11
ACCEPTED MANUSCRIPT ABBREVIATIONS
1- ASA – American Society of anesthesiologists 2- BMI – Body mass index 3- CMS– Centers for Medicare and Medicaid Services
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4- CKD – Chronic kidney disease 5- EBL – Estimated blood loss 6- ER – Emergency Room 7- eGFR – Estimated Glomerular Filtration Rate
SC
8- HHS– Health and Human Services 9- HRRP – Hospital Readmission Reduction Program
11- LOS – Length of hospital stay
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10- IRB – Institutional review board
12- R.E.N.A.L. – radius, exophytic/endophitic, nearness to collecting system or sinus, anterior/posterior, and location relative to polar lines 13- RPN – Robotic partial nephrectomy
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14- WIT – Warm ischemia time
S0022-5347(14)00260-2 10.1016/j.juro.2014.02.009 JURO 11096
To appear in: The Journal of Urology Accepted Date: 7 February 2014 Please cite this article as: Brandao LF, Zargar H, Laydner H, Akca O, Autorino R, Ko O, Samarasekera D, Li J, Rabets J, Krishnan J, Haber GP, Kaouk J, Stein R, 30-day hospital readmission after robotic partial nephrectomy, are we prepared for Medicare Readmission Reduction Program?, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.02.009. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT 30-day hospital readmission after robotic partial nephrectomy, are we prepared for Medicare Readmission Reduction Program? Luis Felipe Brandao1, Homayoun Zargar1, Humberto Laydner1, Oktay Akca1, Riccardo Autorino1, Oliver Ko2, Dinesh Samarasekera1, Jianbo Li3, John Rabets1,
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Jayram Krishnan1, Georges-Pascal Haber1, Jihad Kaouk1, Robert Stein1
1- Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
SC
2- Case Western Reserve University School of Medicine, Cleveland, Ohio
3- Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland,
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OH, USA.
Robert J. Stein, M.D.,
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Corresponding author:
EP
9500 Euclid Avenue, Glickman Urology and Kidney Institute / Q10-1, Cleveland Clinic. Cleveland, OH, 44195, United States; Tel. +1 216 445-4800; Fax: +1 216 445-2267;
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E-mail: [email protected]
1
ACCEPTED MANUSCRIPT ABSTRACT
INTRODUCTION: After the Centers for Medicare and Medicaid Services introduced the concept of Hospital Readmission Reduction Program, hospitals and health care centers are financially penalized for exceeding specific readmission rates. AND
METHODS:
We
retrospectively
reviewed
our
RI PT
MATERIALS
institutional review board approved database of patients undergoing robotic partial nephrectomy (RPN) at our institution and included patients who were readmitted to any hospital as an inpatient stay within 30 days from discharge after RPN.
SC
RESULTS: From March 2006 to March 2013, 627 patients underwent RPN at our center. Twenty eight (4.46%) patients were readmitted within 30 days of surgery. Postoperative bleeding was responsible for 8 (28.5%) readmissions. Pulmonary
M AN U
embolism was reported in 3 cases and retroperitoneal abscess was diagnosed in 2 patients. Two patients developed urinary leak requiring surgical intervention. Pneumonia was diagnosed in two cases. Two patients were readmitted for chest pain. Overall 9 (32.1%) patients presented with major complications requiring any intervention. On multivariable analysis, Charlson score was the only factor
TE D
significantly associated with a higher 30-day readmission rate (p=0.03). If the Charlson score was ≥ 5, the chance for readmission would be 2.7 times higher. CONCLUSION: Increased comorbidities, specifically Charlson comorbidity index ≥ 5, was the only significant predictor of higher incidence of 30-day
EP
readmission. This information can be useful when counseling patients for RPN procedure and also for determining baseline rates if CMS expand the number of
AC C
conditions they evaluate for excess 30-day readmissions.
2
ACCEPTED MANUSCRIPT INTRODUCTION In October 1st of 2012, the Centers for Medicare and Medicaid Services (CMS) introduced the concept of Hospital Readmission Reduction Program (HRRP). Based on this, hospitals and health care centers are financially penalized for
RI PT
exceeding specific readmission rates. CMS established a methodology to calculate the excess readmission ratio for each applicable condition, which is used, in part, to calculate the readmission payment adjustment. Currently, only the 3 diagnoses of myocardial infarction, congestive heart failure and pneumonia (with clinical
SC
adjustment factors such as comorbidities, patient frailty and demographics) are used as readmission measures for calculating excess readmission ratios. However, there is a plan for expanding the conditions subject to penalty in financial year 2015 1. A
M AN U
recent analysis of Medicare claims data found that 15% of readmissions after primarily surgical care were within 30 days after the discharge 2. Among the readmitted surgical patients 72.6% were hospitalized for medical diagnoses. The study estimated that in 2004 the cost for unplanned rehospitalization for medicare was US$17.4 billion. Beyond financial considerations, the process of readmission affects
TE D
the patients’ overall health journey negatively 3.
There is a paucity of data with regards to 30-day readmission after urological surgery. Given the widespread use of minimally invasive surgery and more recently robotic assisted laparoscopic surgery, it would be of interest to assess the 30-day
EP
readmission rates after such procedures. Herein, we review our robotic partial nephrectomy (RPN) 30-day readmission rate and evaluate the prevalence of factors
AC C
which it may be associated with.
PATIENTS AND METHODS
Patients and data:
We retrospectively reviewed our institutional review board (IRB) approved database of patients undergoing RPN at our center. We included patients who were readmitted to any hospital as an inpatient stay within 30 days from discharge after RPN. Patients were cross-referenced with our electronic medical records for accuracy of the post-operative complications and readmissions. In the case of readmission to another hospital, medical records were obtained and examined. We collected data on 3
ACCEPTED MANUSCRIPT patients’ demographics, tumor characteristics and perioperative events. The demographic parameters assessed were age, gender, race, body mass index, side of tumor, A.S.A. score (American Society of Anesthesiologists), Charlson comorbidity index 4, R.E.N.A.L. nephrometry score
5
and preoperative estimated glomerular
filtration rate (eGFR). The eGFR was calculated by using modification of diet in renal
RI PT
disease (MDRD) formula 6. Chronic kidney disease was defined as an eGFR 2 g/dL, gross hematuria or any clinically overt sign of hemorrhage, regardless whether it required any intervention or not. Urinary leak was defined as persistent drain output more than 48h after the procedure and with drained fluid analysis consistent with urine. Ileus was defined as inability to tolerate a regular diet after 4 days from the
TE D
procedure 8.
Patients were divided in 2 groups (readmitted and non-readmitted) and comparisons between them were made using Wilcoxon rank-sum test for continuous
EP
variables, and chi-squared test for categorical variables. Multivariable logistic regression analysis was applied to identify factors associated with readmission.
AC C
Statistical software R (version 3) and its Regression Modeling Strategies package were used. Results were considered significant when p value was < 0.05.
Surgical technique, post-operative care and discharge: Our surgical technique has been described in detail previously 9. The postoperative care is based on our institutional care pathway, but may have slight variations according to each surgeon’s preference. Intravenous fluids, analgesics, 24 hours of antibiotics, and prophylaxis for deep vein thrombosis usually in the form of knee-high sequential compression stockings were administrated to patients. Hemoglobin levels and hematocrit are monitored daily during the postoperative 4
ACCEPTED MANUSCRIPT period. The Foley catheter and drain are usually removed on the morning after surgery; ambulation is encouraged, and the diet is advanced. Patients are discharged after passage of flatus, tolerating a regular diet, mobilizing and with pain managed with oral medications. Discharge destination was determined on an individual basis and need for in-patient rehabilitation was uncommon. At the time of discharge,
RI PT
patients have a scheduled follow-up appointment within 7-10 days from the surgery. Patients are provided with advice, contact numbers and instructions in the events of any concerns or complications. In the events of complications after hours, patients are assessed by an emergency/family physician and decision for readmission is made
SC
after discussion with the primary urology physician.
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RESULTS
From March 2006 to March 2013, 627 patients underwent RPN at our center. Table 1 shows patient characteristics and operative data. Twenty eight (4.46%) patients were readmitted within 30 days of surgery. The causes for 30-day readmissions, divided according to their respective Charlson cormobidity index and
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body system, and categorized by Clavien grading and interventions (if any) for the complications are outlined in Table 2. The percentages of each Clavien grade are shown in table 3. Median (range) postoperative day of readmission was day 9 (3 – 26)
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and the median (range) length of stay during the readmission was 3 days (1 – 15).
Urological complications:
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Bleeding: Postoperative bleeding presenting as gross hematuria was responsible for 8 (28.5%) readmissions. Seven patients required blood transfusion, including one who required open radical nephrectomy secondary to hemodynamic instability, one was taken to the OR for clot evacuation, four were treated with angioembolization, and one did not require any additional procedures. This patient was observed for 24 hours and discharged with no need for transfusion or any other treatment. Only one patient needed stay in Intensive Care Unit (3 days). Infection: Retroperitoneal abscess was diagnosed in 2 patients. While one patient had a small abscess that was treated conservatively, the second patient presented with a 6.6 cm abscess requiring percutaneous drainage under CT guidance. One patient developed superficial wound infection and another patient developed 5
ACCEPTED MANUSCRIPT pyelonephritis. Both of them resolved after antibiotic therapy. Urine Leak: Two patients developed urinary leak requiring surgical intervention. One was treated with nephrostomy tube insertion and percutaneous drainage. The other patient was treated with retrograde stent insertion. Both patients had spontaneous resolution of their urinary fistulae without the need for further
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procedures.
Non-urological complications:
Thrombo-embolic events: Pulmonary embolism was reported in 3 cases.
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Prompt anticoagulation was performed in all of them. One patient was diagnosed with deep venous thrombosis. He was treated with anticoagulation and discharged after 3 days.
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Infection: Pneumonia was diagnosed in two patients and both were readmitted within the first 10 days after surgery. They were treated with empiric antibiotics and discharged after 4 days.
Cardiac: Two patients were readmitted complaining of chest pain and cardiac evaluation was negative for both patients.
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Minor causes of readmission were promptly diagnosed and treated conservatively such as, gout flare, abdominal pain, ileus and diarrhea. Overall 9 (32.1%) patients presented with major complications requiring intervention. Five (17.8%) of them were treated with sedation and local anesthesia,
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while 3 (two Clavien 3b and one Clavien 4a) required treatment under general anesthesia. One patient required intensive care Unit for hemodynamics control. No
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deaths occurred within 30 days after surgery. Table 3 shows the percentage of each Clavien grade in the readmitted population.
Comparison between the two cohorts: Patients who were readmitted had significantly higher Charlson comorbidity
score (5.8 ± 1.6 vs 5.1 ± 1.8; p=0.02). There were no significant differences between the non-readmitted and the readmitted groups, in terms of age (58.3 ± 12.3 vs 58.6 ± 14.1; p= 0.94), BMI (30.5 ± 7.0 vs 31.6 ± 6.8; p= 0.28), tumor size (3.2 ± 1.6 vs 3.1 ± 1.5; p= 0.7), R.E.N.A.L median (range) nephrometry score (7 (4 – 12) vs 6 (4 – 11); p= 0.71), Operative time (181.9 ± 53.7 vs 191.3 ± 41.2; p= 0.24), mean EBL (239.9 ± 256 vs 193 ± 135.2; p=0.63), mean LOS (3.4 ± 1.7 vs 4.0 ± 2.4; p=0.13) and mean 6
ACCEPTED MANUSCRIPT WIT (21.4 ± 8.7 vs 21.5 ± 6.2; p= 0.58). Comparing the preoperative and postoperative incidence of CKD (eGFR < 60 ml/min/1.73m2), we observed no difference between non-readmitted and readmitted groups (15.1% vs 20.7%, and 15.9% vs 20%; p=0.57 and p=0.86, respectively). On univariable analysis, these were not associated with an increased risk of readmission
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(p=0.41 and p=0.63 for preoperative and postoperative CKD respectively).
Factors predicting readmission:
On univariable analysis, Charlson Comorbidity Score was found to be
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significantly associated with readmission rate (p=0.03). Length of stay and race (African-American) trended for higher readmission, but did not reach significance (p=0.09 and 0.07, respectively).
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On multivariable analysis, Charlson score was the only factor significantly associated with a higher 30-day readmission rate. If the Charlson score was ≥ 5, the chance for readmission would be 2.77 times higher (CI 95% = 1.10 – 6.94; p=0.03). LOS trended to increasing the likelihood of readmission (p=0.08). Univariable and
DISCUSSION
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multivariable analyses are shown in table 4.
The concept of 30-day readmission rate after surgical procedures is not new.
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However, this data is not consistently reported. Commonly used surgical complication grading systems 7,10 do not include hospital readmission as a specific criteria, to grade
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complications. Also, because readmission can take place in a different facility from where the index admission occurred, the true incidence is potentially underestimated. The Affordable Care Act of 201011 requires the U.S. Department of Health & Human Services (HHS) to establish a readmission reduction program. This program, effective since October 1, 2012, is intended to provide incentives for hospitals to implement strategies to reduce the number of costly and unnecessary hospital readmissions. This is likely to lead to better documentation and enhanced reporting of such data in the literature. It is important to report the specialty and procedure specific data and to analyze their variations, in order to identify factors associated with higher 30-day readmission and formulate prevention strategies.
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ACCEPTED MANUSCRIPT A recent study reported the 30-day readmission after robotic radical prostatectomy
12
. On review of over 100 manuscripts published on the subject of
robotic partial nephrectomy (RPN) in 2013, we identified only 4 that reported the readmission rate in the results section
13-16
. To our knowledge, this study is the first
one focusing on the 30-day readmission after robotic partial nephrectomy (RPN) and
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assessing the factors contributing to it. In our series the rate of 30-day readmission was 4.4 % for all causes. The reported 30-day readmission rate for RPN in published literature ranges from 0 to 8%, as shown in Table 5. The reported rate of 30-day readmission for robotic prostatectomy is 3.5%12 and for robotic radical cystectomy is within reported range of
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18-28%17,18. Thirty-day readmission rate in our present series is lower than the reported readmission rates for other nephron sparing surgical modalities. In a
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cohort of 2321 patients, Tan and colleagues reported, 30-day re-hospitalization rates of 9.7 and 9% for laparoscopic and open partial nephrectomy, respectively 19
. Nogueira et al presented a readmission rate of 10.4% for laparoscopic partial
nephrectomy in a single center series of 144 patients
20
. Direct comparison
between these studies given the differences in patient demographics, characteristics of
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the specific pathology, and difference in procedures is not possible; however it provides a framework for overall comparison when contemplating morbidity of each procedure. This data can also be utilized when counseling patients for RPN. As already mentioned, readmission can take place in a different facility from where
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the index admission occurred, which can translate into an underestimation of the true incidence. This issue has been overcome in our study by obtaining and
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recording events occurring in other hospitals. Among the studies included in Table 5, only Abaza et al addressed this issue by assessing and recording ED visits and readmissions to other hospitals based on self-reporting by patients15. On multivariable analysis, higher patient comorbidity index was the only
predictor of increased 30-day readmission in our cohort. None of the traditional factors predicting complications, i.e. BMI duration of surgery
12
21
, R.E.N.A.L nephrometry score
22,23
or
were associated with a difference in readmission rate. With an
aging population and improvements in medical technology, we may be offering nephron sparing surgery to an older population with more medical co-morbidities. Patients with more co-morbidities are more likely to have postoperative complications 24
and as shown in this study have a higher incidence of 30-day readmission. 8
ACCEPTED MANUSCRIPT An additional consideration is that referral centers may tend to receive more complex patients than other hospitals. Based on reports such as this, CMS could consider using a correction factor according to the comorbidity of the population treated in each institution. An undesired effect otherwise may be hospitals attempting to create mechanisms to restrict the first admission of patients with more comorbid
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conditions or indicated readmission, in efforts to avoid Medicare reimbursement cuts. Use of retrospective data from a single institution is the main limitation of this study. Given the high volume nature of our RPN practice, these results might not be applicable to other settings. To our knowledge, this is the first study specifically
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reporting on the 30-day readmission after RPN.
Conclusion:
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The 30-day readmission rate after robotic partial nephrectomy in our series was 4.4%. Increased comorbidities, specifically Charlson comorbidity index of ≥ 5, was the only significant predictor of higher incidence of 30-day readmission. This information can be used when counseling patients for RPN procedure. Studies such as these may also be used to determine reference readmission rates if CMS plans to
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REFERENCES:
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expand the number of conditions they evaluate for excess 30-day readmissions.
1. (Accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
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Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html. Accessed on November 30th, 2013)
2. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009;360:1418-28.
3. Hinami K, Bilimoria KY, Kallas PG, Simons YM, Christensen NP, Williams MV. Patient experiences after hospitalizations for elective surgery. Am J Surg 2013. 4. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. Journal of chronic diseases 1987;40:373-83.
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ACCEPTED MANUSCRIPT 5. Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol 2009;182:844-53. 6. Levey AS, Coresh J, Greene T, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for
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estimating glomerular filtration rate. Ann Intern Med 2006;145:247-54. 7. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13.
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8. Vather R, Trivedi S, Bissett I et al Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg, 2013 May;17(5):962-72
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9. Kaouk JH, Khalifeh A, Hillyer S, Haber GP, Stein RJ, Autorino R. Robotassisted laparoscopic partial nephrectomy: step-by-step contemporary technique and surgical outcomes at a single high-volume institution. Eur Urol 2012;62:553-61.
10. Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in
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reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol 2013;190:1271-4. 11. Patient Protection and Affordable Care Act. . Pub L No 111-148. 12. Pilecki MA, McGuire BB, Jain UK, Kim J, Nadler RB. National multi-
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institutional comparison of 30-day post-operative complication and readmission rates between open retropubic radical prostatectomy (RRP)
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and robot-assisted laparoscopic prostatectomy (RALRP) using NSQIP. J Endourol 2013.
13. Khalifeh A, Autorino R, Hillyer SP, et al. Comparative outcomes and assessment of trifecta in 500 robotic and laparoscopic partial nephrectomy cases: a single surgeon experience. J Urol 2013;189:123642. 14. Patel A, Golan S, Razmaria A, Prasad S, Eggener S, Shalhav A. Early discharge after laparoscopic or robotic partial nephrectomy: care pathway evaluation. BJU Int 2013.
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ACCEPTED MANUSCRIPT 15. Abaza R, Shah K. A single overnight stay is possible for most patients undergoing robotic partial nephrectomy. Urology 2013;81:301-6. 16. Alemozaffar M, Chang SL, Kacker R, Sun M, DeWolf WC, Wagner AA. Comparing costs of robotic, laparoscopic, and open partial nephrectomy. J Endourol 2013;27:560-5.
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17. Styn NR, Montgomery JS, Wood DP, et al. Matched comparison of roboticassisted and open radical cystectomy. Urology 2012;79:1303-8.
18. Kader AK, Richards KA, Krane LS, Pettus JA, Smith JJ, Hemal AK. Robotassisted laparoscopic vs open radical cystectomy: comparison of
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complications and perioperative oncological outcomes in 200 patients. BJU Int 2013;112:E290-4.
19. Tan HJ, Wolf JS, Miller DC et al. Population-level assessment of the
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hospital-based outcomes following laparoscopic versus open partial nephrectomy during the adoption of minimally-invasive surgery. J Urol. 2013; Nov 7 (Epub ahead of print)
20. Nogueira L, Katz Darren, Coleman JA, et al. Critical Evaluation of perioperative complications in laparoscopic partial nephrectomy.
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Urology. 2010;75:288-294.
21. Amri R, Bordeianou LG, Sylla P, Berger DL. Obesity, outcomes and quality of care: body mass index increases the risk of wound-related complications in colon cancer surgery. Am J Surg 2013.
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22. Simhan J, Smaldone MC, Tsai KJ, et al. Objective measures of renal mass anatomic complexity predict rates of major complications following
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partial nephrectomy. Eur Urol 2011;60:724-30.
23. Liu ZW, Olweny EO, Yin G, et al. Prediction of perioperative outcomes following minimally invasive partial nephrectomy: role of the R.E.N.A.L nephrometry score. World journal of urology 2013;31:1183-9.
24. Revenig LM, Canter DJ, Taylor MD, et al. Too frail for surgery? Initial results of a large multidisciplinary prospective study examining preoperative variables predictive of poor surgical outcomes. Journal of the American College of Surgeons 2013;217:665-70 e1.
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ACCEPTED MANUSCRIPT ABBREVIATIONS
1- ASA – American Society of anesthesiologists 2- BMI – Body mass index 3- CMS– Centers for Medicare and Medicaid Services
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4- CKD – Chronic kidney disease 5- EBL – Estimated blood loss 6- ER – Emergency Room 7- eGFR – Estimated Glomerular Filtration Rate
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8- HHS– Health and Human Services 9- HRRP – Hospital Readmission Reduction Program
11- LOS – Length of hospital stay
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10- IRB – Institutional review board
12- R.E.N.A.L. – radius, exophytic/endophitic, nearness to collecting system or sinus, anterior/posterior, and location relative to polar lines 13- RPN – Robotic partial nephrectomy
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14- WIT – Warm ischemia time
