Jesse D. Sammon

Perioperative Outcomes of Robot-Assisted Radical Prostatectomy Compared With Open Radical Prostatectomy: Results From the Nationwide Inpatient Sample

BACKGROUND Prior to the introduction and dissemination of robot-assisted radical prostatectomy (RARP), population-based studies comparing open radical prostatectomy (ORP) and minimally invasive radical prostatectomy (MIRP) found no clinically significant difference in perioperative complication rates. OBJECTIVE Assess the rate of RARP utilization and reexamine the difference in perioperative complication rates between RARP and ORP in light of RARPs supplanting laparoscopic radical prostatectomy (LRP) as the most common MIRP technique. DESIGN, SETTING, AND PARTICIPANTS As of October 2008, a robot-assisted modifier was introduced to denote robot-assisted procedures. Relying on the Nationwide Inpatient Sample between October 2008 and December 2009, patients treated with radical prostatectomy (RP) were identified. The robot-assisted modifier (17.4x) was used to identify RARP (n=11 889). Patients with the minimally invasive modifier code (54.21) without the robot-assisted modifier were classified as having undergone LRP and were removed from further analyses. The remainder were classified as ORP patients (n=7389). INTERVENTION All patients underwent RARP or ORP. MEASUREMENTS We compared the rates of blood transfusions, intraoperative and postoperative complications, prolonged length of stay (pLOS), and in-hospital mortality. Multivariable logistic regression analyses of propensity score-matched populations, fitted with general estimation equations for clustering among hospitals, further adjusted for confounding factors. RESULTS AND LIMITATIONS Of 19 462 RPs, 61.1% were RARPs, 38.0% were ORPs, and 0.9% were LRPs. In multivariable analyses of propensity score-matched populations, patients undergoing RARP were less likely to receive a blood transfusion (odds ratio [OR]: 0.34; 95% confidence interval [CI], 0.28-0.40), to experience an intraoperative complication (OR: 0.47; 95% CI, 0.31-0.71) or a postoperative complication (OR: 0.86; 95% CI, 0.77-0.96), and to experience a pLOS (OR: 0.28; 95% CI, 0.26-0.30). Limitations of this study include lack of adjustment for tumor characteristics, surgeon volume, learning curve effect, and longitudinal follow-up. CONCLUSIONS RARP has supplanted ORP as the most common surgical approach for RP. Moreover, we demonstrate superior adjusted perioperative outcomes after RARP in virtually all examined outcomes.

Practice Patterns and Outcomes of Open and Minimally Invasive Partial Nephrectomy Since the Introduction of Robotic Partial Nephrectomy: Results from the Nationwide Inpatient Sample

PURPOSE We determined practice patterns and perioperative outcomes of open and minimally invasive partial nephrectomy in the United States since the introduction of a robot-assisted modifier in the Nationwide Inpatient Sample. MATERIALS AND METHODS We identified all patients with nonmetastatic disease treated with open, laparoscopic or robotic partial nephrectomy in the Nationwide Inpatient Sample between October 2008 and December 2010. Utilization rates were assessed by year, patient and hospital characteristics. We evaluated the perioperative outcomes of open vs robotic and open vs laparoscopic partial nephrectomy using binary logistic regression models adjusted for patient and hospital covariates. RESULTS In a weighted sample of 38,064 partial nephrectomies 66.9%, 23.9% and 9.2% of the procedures were open, robotic and laparoscopic operations, respectively. In 2010 the relative annual increase in open, robotic and laparoscopic partial nephrectomy was 7.9%, 45.4% and 6.1%, respectively. Compared to open partial nephrectomy patients treated with minimally invasive partial nephrectomy were less likely to receive blood transfusion (robotic vs laparoscopic OR 0.56, p <0.001 vs OR 0.68, p = 0.016), postoperative complication (OR 0.63, p <0.001 vs OR 0.78, p <0.009) or prolonged length of stay (OR 0.27 vs OR 0.41, each p <0.001). Only patients who underwent the robotic procedure were less likely to experience an intraoperative complication (robotic vs laparoscopic OR 0.69, p = 0.014 vs OR 0.67, p = 0.069). Excess hospital charges were higher after robotic surgery (OR 1.35, p <0.001). CONCLUSIONS The dissemination of robotic surgery for partial nephrectomy in the United States has been rapid and safe. Compared to open partial nephrectomy the robotic procedure had lower odds than laparoscopic partial nephrectomy for most study outcomes except hospital charges. Robotic partial nephrectomy has now supplanted laparoscopic partial nephrectomy as the most common minimally invasive approach for partial nephrectomy.

Comparative Effectiveness of Robot-Assisted and Open Radical Prostatectomy in the Postdissemination Era

PURPOSE Given the lack of randomized trials comparing robot-assisted radical prostatectomy (RARP) and open radical prostatectomy (ORP), we sought to re-examine the outcomes of these techniques using a cohort of patients treated in the postdissemination era. PATIENTS AND METHODS Overall, data from 5,915 patients with prostate cancer treated with RARP or ORP within the SEER-Medicare linked database diagnosed between October 2008 and December 2009 were abstracted. Postoperative complications, blood transfusions, prolonged length of stay (pLOS), readmission, additional cancer therapies, and costs of care within the first year after surgery were compared between the two surgical approaches. To decrease the effect of unmeasured confounders, instrumental variable analysis was performed. Multivariable logistic regression analyses were then performed. RESULTS Overall, 2,439 patients (41.2%) and 3,476 patients (58.8%) underwent ORP and RARP, respectively. In multivariable analyses, patients undergoing RARP had similar odds of overall complications, readmission, and additional cancer therapies compared with patients undergoing ORP. However, RARP was associated with a higher probability of experiencing 30- and 90-day genitourinary and miscellaneous medical complications (all P ≤ .02). Additionally, RARP led to a lower risk of experiencing blood transfusion and of having a pLOS (all P < .001). Finally, first-year reimbursements were greater for patients undergoing RARP compared with ORP (P < .001). CONCLUSION RARP and ORP have comparable rates of complications and additional cancer therapies, even in the postdissemination era. Although RARP was associated with lower risk of blood transfusions and a slightly shorter length of stay, these benefits do not translate to a decrease in expenditures.

Chronic Kidney Disease After Nephrectomy in Patients with Small Renal Masses: A Retrospective Observational Analysis

CONTEXT Chronic kidney disease (CKD) is a worldwide health threat associated with increased cardiovascular disease and mortality. OBJECTIVE To examine postoperative CKD in patients with small renal masses (SRMs) treated with partial nephrectomy (PN) or radical nephrectomy (RN). DESIGN, SETTING, AND PARTICIPANTS A US National Cancer Institute Surveillance Epidemiology and End Results (SEER)-Medicare-linked retrospective cohort of 4633 T1aN0M0 renal cell carcinoma (RCC) patients who underwent PN or RN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome of interest was the onset of CKD stage ≥3. Secondary end points comprised acute renal failure (ARF), chronic renal insufficiency (CRI), anemia in CKD, and end-stage renal disease (ESRD). Kaplan-Meier and Cox regression analyses were performed. RESULTS AND LIMITATIONS Postpropensity matching resulted in 840 RN and PN patients. In multivariable analyses, RN patients were 1.9-, 1.4-, 1.8-, and 1.8-fold more likely to have an occurrence of CKD, ARF, CRI, and anemia in CKD, respectively (all p ≤ 0.004). The risk of ESRD between treatment groups failed to achieve statistical significance (p=0.06). CONCLUSIONS PN is associated with more favorable postoperative renal function outcomes relative to RN in the setting of SRMs.

Safety Profile of Robot-Assisted Radical Prostatectomy: A Standardized Report of Complications in 3317 Patients

BACKGROUND Previous studies attempting to assess complications after robot-assisted radical prostatectomy (RARP) are limited by their small numbers, short follow-up, or lack of risk factor analysis. OBJECTIVE To document complications after RARP by strict application of standardized reporting criteria. DESIGN, SETTING, AND PARTICIPANTS Between January 2005 and December 2009, 3317 consecutive patients underwent RARP at a tertiary referral center. Median follow-up was 24.2 mo (interquartile range: 12.4-36.9). INTERVENTION Transperitoneal RARP was performed by one of five surgeons-two experienced, three beginners. MEASUREMENTS Complications were captured by exhaustive review of multiple datasets, including our prospective prostate cancer database, claims data, and electronic medical and institutional morbidity and mortality records, and reported according to the Martin-Donat criteria. Complications were stratified by type (medical/surgical), Clavien classification, and timing of onset. Multivariable analysis of factors predictive of complications was performed. RESULTS AND LIMITATIONS The median hospitalization time was 1 d. There were 368 complications in 326 patients (9.8%), including a transfusion rate of 2.2%. We detected 79 medical complications in 78 patients (2.4%) and 289 surgical complications in 264 patients (8.0%). There were 242 minor (Clavien 1-2) and 126 major (Clavien 3-5) complications. Two hundred ninety-nine (81.3%) complications occurred within 30 d, 17 (4.6%) within 31-90 d, and 52 (14.1%) after 90 d from surgery. On multivariable analysis, preoperative prostate-specific antigen values and cardiac comorbidity were predictive for medical complications, whereas age, gastroesophageal reflux disease, and biopsy Gleason score were predictive of surgical complications. Limitations of this study include representing results from a single high-volume referral center and not including the learning curve of the two most experienced surgeons. CONCLUSIONS RARP is a safe operation, with an overall complication rate of 9.8%. Most complications occurred within 30 d of surgery.

Prostate-Specific Antigen Screening After 2012 US Preventive Services Task Force Recommendations

Prostate-Specific Antigen Screening After 2012 US Preventive Services Task Force Recommendations Prostate-specific antigen (PSA) screening is a widely debated practice in the United States, given that PSA screening can lead to the diagnosis of nonlethal prostate cancer and the harms associated with treatment of such disease.1 In this context, the 2008 US Preventive Services Task Force (USPSTF) panel recommended against PSA screening in men older than 75 years. This recommendation, however, has been ineffective at reducing the observed prevalence of PSA screening among older men.2 More recently, the USPSTF issued a grade D recommendation against PSA screening for all men, regardless of age.3

Identifying optimal candidates for local treatment of the primary tumor among patients diagnosed with metastatic prostate cancer: a SEER-based study.

UNLABELLED A recent study observed a survival benefit in men diagnosed with metastatic prostate cancer (mPCa) and managed with local treatment of the primary tumor (LT; either radical prostatectomy plus pelvic lymph node dissection or radiation therapy). We tested the hypothesis that only specific mPCa patients would benefit from LT and that the potential benefit would vary based on primary tumor characteristics. A total of 8197 mPCa patients at diagnosis (M1a, M1b, and M1c) were identified using the Surveillance Epidemiology and End Results database (2004-2011) and were divided according to treatment type: LT versus nonlocal treatment of the primary tumor (NLT; either androgen deprivation therapy or observation). Multivariable Cox regression analysis was used to predict cancer-specific mortality (CSM) in patients that received NLT. To assess whether the benefit of LT was different by baseline risk, we tested an interaction with CSM risk and LT. At multivariable analysis, all predictors were significantly associated with CSM, and the interaction test was statistically significant (p<0.0001). Local treatment of the primary tumor, compared with NLT, conferred a higher CSM-free survival rate in patients with a predicted CSM risk <40%. The number needed to treat according to the predicted CSM risk at 3 yr after diagnosis remained substantially constant from 10% to 30%, whereas it exponentially increased for predicted CSM risk >40%. These results should serve as a foundation for future prospective trials. PATIENT SUMMARY Among metastatic prostate cancer patients, the potential benefit of local treatment to the primary tumor depends greatly on tumor characteristics, and patient selection is essential to avoid either over- or undertreatment.

Barbed Suture for Renorrhaphy During Robot-Assisted Partial Nephrectomy

BACKGROUND AND PURPOSE Robot-assisted partial nephrectomy (RAPN) is an emerging technique for minimally invasive nephron-sparing surgery that may facilitate the technical challenges of sutured renorrhaphy. Barbed suture allows for knotless wound closure and improves suturing efficiency. We present the first clinical study of barbed suture for renorrhaphy during RAPN in human patients and compare perioperative outcomes to RAPN with polyglactin suture. PATIENTS AND METHODS Thirty consecutive patients underwent RAPN by a single surgeon; 15 using polyglactin suture for renorrhaphy followed by 15 using the V-Loc 180 wound closure device. Renorrhaphy was performed in two layers, with a continuous running closure of deep vessels and the collecting system, followed by a running closure of the renal capsule, using the sliding Hem-o-lok clip technique. Operative characteristics and complications were compared between groups. RESULTS Renorrhaphy was successfully completed in all 30 consecutive RAPN procedures. V-Loc and conventional groups were equivalent in demographic and tumor characteristics. Mean operative and console time were equivalent; warm ischemia time was significantly shorter in the V-Loc group (18.5 vs 24.7 min, P = 0.008). There were no instances of suture slippage or tearing in the barbed suture group. The barbs held the sliding clip renorrhaphy intact without the need for redundant clips to prevent backsliding. CONCLUSION Use of barbed suture simplifies the renorrhaphy technique during RAPN and improves efficiency, allowing for reduced warm ischemia times. We demonstrate feasibility and safety of this suture technique in human patients undergoing minimally invasive partial nephrectomy.

Robot-Assisted Versus Open Radical Prostatectomy: The Differential Effect of Regionalization, Procedure Volume and Operative Approach

PURPOSE The use of robot-assisted radical prostatectomy has increased rapidly despite the absence of randomized, controlled trials showing the superiority of this approach. While recent studies suggest an advantage for perioperative complication rates, they fail to account for the volume-outcome relationship. We compared perioperative outcomes after robot-assisted and open radical prostatectomy, while considering the impact of this established relationship. MATERIALS AND METHODS Using the NIS (Nationwide Inpatient Sample), we abstracted data on patients treated with radical prostatectomy in 2009. Univariable and multivariable logistic regression analyses were done to compare the rates of blood transfusion, intraoperative and postoperative complications, prolonged length of stay, increased hospital charges and mortality between robot-assisted and open radical prostatectomy overall and across volume quartiles. RESULTS An estimated 77,616 men underwent radical prostatectomy, including a robot-assisted and an open procedure in 63.9% and 36.1%, respectively. Low volume centers averaged 26.2 robot-assisted and 5.2 open cases, while very high volume centers averaged 578.8 robot-assisted and 150.2 open cases. Overall, patients treated with the robot-assisted procedure experienced a lower rate of adverse outcomes than those treated with the open procedure for all measured categories. Across equivalent volume quartiles robot-assisted radical prostatectomy outcomes were generally favorable. However, the open procedure at high volume centers resulted in a lower postoperative complication rate (OR 0.59, 95% CI 0.46-0.75), elevated hospital charges (OR 0.75, 95% CI 0.64-0.87) and a comparable blood transfusion rate (OR 1.38, 95% CI 0.93-2.02) relative to the robot-assisted procedure at low volume centers. CONCLUSIONS Regionalization has occurred to a greater extent for robot-assisted than for open radical prostatectomy with an associated benefit in overall outcomes. Nonetheless, low volume institutions experienced inferior outcomes relative to the highest volume centers irrespective of approach. These findings demonstrate the importance of accounting for hospital volume when examining the benefit of a surgical technique.

A Novel Method of Urethrovesical Anastomosis During Robot-Assisted Radical Prostatectomy Using a Unidirectional Barbed Wound Closure Device: Feasibility Study and Early Outcomes in 51 Patients

PURPOSE To describe the safety and feasibility of a running urethrovesical anastomosis (UVA) in robot-assisted radical prostatectomy (RARP) using a unidirectional self-locking barbed suture. PATIENTS AND METHODS Fifty-one consecutive patients with organ-confined prostate cancer underwent RARP by one of two experienced surgeons. UVA was performed in two layers, using a unidirectional barbed suture fashioned into a double-ended stitch. Perioperative outcomes and 30-day complications were recorded. RESULTS All anastomoses were performed without assistance and without tying a knot. Median time for entire dual-layer anastomosis was 14.0 minutes (interquartile range [IQR]: 12-20) and that for urethrovesical anastomosis was 11 minutes (IQR: 9-15). Not having to rely on an assistant to follow the suture decreased instrument clashes, entangling of the suture around an instrument, and made the anastomosis faster. Eight patients underwent anterior/lateral reconstruction of the bladder neck, and there were no leaks on cystography at 1 week. CONCLUSIONS We describe the first reported clinical experience with a novel technique of performing UVA during RARP that is safe and efficient. Using the barbed wound closure device prevents slippage, precluding the need for assistance, knot tying, and constant reassessing of anastomosis integrity.