Keith J. Kowalczyk

Use, Costs and Comparative Effectiveness of Robotic Assisted, Laparoscopic and Open Urological Surgery

PURPOSE Although robotic assisted laparoscopic surgery has been aggressively marketed and rapidly adopted, there are few comparative effectiveness studies that support its purported advantages compared to open and laparoscopic surgery. We used a population based approach to assess use, costs and outcomes of robotic assisted laparoscopic surgery vs laparoscopic surgery and open surgery for common robotic assisted urological procedures. MATERIALS AND METHODS From the Nationwide Inpatient Sample we identified the most common urological robotic assisted laparoscopic surgery procedures during the last quarter of 2008 as radical prostatectomy, nephrectomy, partial nephrectomy and pyeloplasty. Robotic assisted laparoscopic surgery, laparoscopic surgery and open surgery use, costs and inpatient outcomes were compared using propensity score methods. RESULTS Robotic assisted laparoscopic surgery was performed for 52.7% of radical prostatectomies, 27.3% of pyeloplasties, 11.5% of partial nephrectomies and 2.3% of nephrectomies. For radical prostatectomy robotic assisted laparoscopic surgery was more prevalent than open surgery among white patients in high volume, urban hospitals (all p≤0.015). Geographic variations were found in the use of robotic assisted laparoscopic surgery vs open surgery. Robotic assisted laparoscopic surgery and laparoscopic surgery vs open surgery were associated with shorter length of stay for all procedures, with robotic assisted laparoscopic surgery being the shortest for radical prostatectomy and partial nephrectomy (all p<0.001). For most procedures robotic assisted laparoscopic surgery and laparoscopic surgery vs open surgery resulted in fewer deaths, complications, transfusions and more routine discharges. However, robotic assisted laparoscopic surgery was more costly than laparoscopic surgery and open surgery for most procedures. CONCLUSIONS While robotic assisted and laparoscopic surgery are associated with fewer deaths, complications, transfusions and shorter length of hospital stay compared to open surgery, robotic assisted laparoscopic surgery is more costly than laparoscopic and open surgery. Additional studies are needed to better delineate the comparative and cost-effectiveness of robotic assisted laparoscopic surgery relative to laparoscopic surgery and open surgery.

Comparative Analysis of Outcomes and Costs Following Open Radical Cystectomy Versus Robot-Assisted Laparoscopic Radical Cystectomy: Results From the US Nationwide Inpatient Sample

BACKGROUND Although robot-assisted laparoscopic radical cystectomy (RARC) was first reported in 2003 and has gained popularity, comparisons with open radical cystectomy (ORC) are limited to reports from high-volume referral centers. OBJECTIVE To compare population-based perioperative outcomes and costs of ORC and RARC. DESIGN, SETTING, AND PARTICIPANTS A retrospective observational cohort study using the US Nationwide Inpatient Sample to characterize 2009 RARC compared with ORC use and outcomes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Propensity score methods were used to compare inpatient morbidity and mortality, lengths of stay, and costs. RESULTS AND LIMITATIONS We identified 1444 ORCs and 224 RARCs. Women were less likely to undergo RARC than ORC (9.8% compared with 15.5%, p = 0.048), and 95.7% of RARCs and 73.9% of ORCs were performed at teaching hospitals (p<0.001). In adjusted analyses, subjects undergoing RARC compared with ORC experienced fewer inpatient complications (49.1% and 63.8%, p = 0.035) and fewer deaths (0% and 2.5%, p<0.001). RARC compared with ORC was associated with lower parenteral nutrition use (6.4% and 13.3%, p = 0.046); however, there was no difference in length of stay. RARC compared with ORC was

Temporal National Trends of Minimally Invasive and Retropubic Radical Prostatectomy Outcomes from 2003 to 2007: Results from the 100% Medicare Sample

3797 more costly (p = 0.023). Limitations include retrospective design, absence of tumor characteristics, and lack of outcomes beyond hospital discharge. CONCLUSIONS RARC is associated with lower parenteral nutrition use and fewer inpatient complications and deaths. However, lengths of stay are similar, and the robotic approach is significantly more costly.

Athermal Division and Selective Suture Ligation of the Dorsal Vein Complex During Robot-Assisted Laparoscopic Radical Prostatectomy: Description of Technique and Outcomes

BACKGROUND Although the use of minimally invasive radical prostatectomy (MIRP) has increased, there are few comprehensive population-based studies assessing temporal trends and outcomes relative to retropubic radical prostatectomy (RRP). OBJECTIVE Assess temporal trends in the utilization and outcomes of MIRP and RRP among US Medicare beneficiaries from 2003 to 2007. DESIGN, SETTING, AND PARTICIPANTS A population-based retrospective study of 19 594 MIRP and 58 638 RRP procedures was performed from 2003 to 2007 from the 100% Medicare sample, composed of almost all US men ≥ 65 yr of age. INTERVENTION MIRP and RRP. MEASUREMENTS We measured 30-d outcomes (cardiac, respiratory, vascular, genitourinary, miscellaneous medical, miscellaneous surgical, wound complications, blood transfusions, and death), cystography utilization within 6 wk of surgery, and late complications (anastomotic stricture, ureteral complications, rectourethral fistulae, lymphocele, and corrective incontinence surgery). RESULTS AND LIMITATIONS From 2003 to 2007, MIRP increased from 4.9% to 44.5% of radical prostatectomies while RRP decreased from 89.4% to 52.9%. MIRP versus RRP subjects were younger (p<0.001) and had fewer comorbidities (p<0.001). Decreased MIRP genitourinary complications (6.2-4.1%; p = 0.002), miscellaneous surgical complications (4.7-3.7%; p=0.030), transfusions (3.5-2.2%; p=0.005), and postoperative cystography utilization (40.3-34.1%; p<0.001) were observed over time. Conversely, overall RRP perioperative complications increased (27.4-32.0%; p<0.001), including an increase in perioperative mortality (0.5-0.8%, p=0.009). Late RRP complications increased, with the exception of fewer anastomotic strictures (10.2-8.8%; p=0.002). In adjusted analyses, RRP versus MIRP was associated with increased 30-d mortality (odds ratio [OR]: 2.67; 95% confidence interval [CI], 1.55-4.59; p<0.001) and more perioperative (OR: 1.60; 95% CI, 1.45-1.76; p<0.001) and late complications (OR: 2.52; 95% CI, 2.20-2.89; p<0.001). Limitations include the inability to distinguish MIRP with versus without robotic assistance and also the lack of pathologic information. CONCLUSIONS From 2003 to 2007, there were fewer MIRP transfusions, genitourinary complications, and miscellaneous surgical complications, whereas most RRP perioperative and late complications increased. RRP versus MIRP was associated with more postoperative mortality and complications.

Hospital volume, utilization, costs and outcomes of robot-assisted laparoscopic radical prostatectomy.

BACKGROUND Apical dissection and control of the dorsal vein complex (DVC) affects blood loss, apical positive margins, and urinary control during robot-assisted laparoscopic radical prostatectomy (RALP). OBJECTIVE To describe technique and outcomes for athermal DVC division followed by selective suture ligation (DVC-SSL) compared with DVC suture ligation followed by athermal division (SL-DVC). DESIGN, SETTINGS, AND PARTICIPANTS Retrospective study of prospectively collected data from February 2008 to July 2010 for 303 SL-DVC and 240 DVC-SSL procedures. SURGICAL PROCEDURE RALP with comparison of DVC-SSL prior to anastomosis versus early SL-DVC prior to bladder-neck dissection. MEASUREMENTS Blood loss, transfusions, operative time, apical and overall positive margins, urine leaks, catheterization duration, and urinary control at 5 and 12 mo evaluated using 1) the Expanded Prostate Cancer Index (EPIC) urinary function scale and 2) continence defined as zero pads per day. RESULTS AND LIMITATIONS Men who underwent DVC-SSL versus SL-DVC were older (mean: 59.9 vs 57.8 yr, p<0.001), and relatively fewer white men underwent DVC-SSL versus SL-DVC (87.5% vs 96.7%, p<0.001). Operative times were also shorter for DVC-SSL versus SL-DVC (mean: 132 vs 147 min, p<0.001). Men undergoing DVC-SSL versus SL-DVC experienced greater blood loss (mean: 184.3 vs 175.6 ml, p=0.033), and one DVC-SSL versus zero SL-DVC were transfused (p=0.442). Overall (12.2% vs 12.0%, p=1.0) and apical (1.3% vs 2.7%, p=0.361) positive surgical margins were similar for DVC-SSL versus SL-DVC. Although 5-mo postoperative urinary function (mean: 72.9 vs 55.4, p<0.001) and continence (61.4% vs 39.6%, p<0.001) were better for DVC-SSL versus SL-DVC, 12-mo urinary outcomes were similar. In adjusted analyses, DVC-SSL versus SL-DVC was associated with shorter operative times (parameter estimate [PE]±standard error [SE]: 16.84±2.56, p<0.001), and better 5-mo urinary function (PE±SE: 19.93±3.09, p<0.001) and continence (odds ratio 3.39, 95% confidence interval 2.07-5.57, p<0.001). CONCLUSIONS DVC-SSL versus SL-DVC improves early urinary control and shortens operative times due to fewer instrument changes with late versus early DVC control.

Venous Thromboembolism After Major Cancer Surgery: Temporal Trends and Patterns of Care

PURPOSE Although robot-assisted laparoscopic radical prostatectomy has been aggressively marketed and rapidly adopted, there is a paucity of population based utilization, outcome and cost data. High vs low volume hospitals have better outcomes for open and minimally invasive radical prostatectomy (robotic or laparoscopic) but to our knowledge volume outcomes effects for robot-assisted laparoscopic radical prostatectomy alone have not been studied. MATERIALS AND METHODS We characterized robot-assisted laparoscopic radical prostatectomy outcome by hospital volume using the Nationwide Inpatient Sample during the last quarter of 2008. Propensity scoring methods were used to assess outcomes and costs. RESULTS At high volume hospitals robot-assisted laparoscopic radical prostatectomy was more likely to be done on men who were white with an income in the highest quartile and age less than 50 years than at low volume hospitals (each p <0.01). Hospitals at above the 50th volume percentile were less likely to show miscellaneous medical and overall complications (p = 0.01). Low vs high volume hospitals had longer mean length of stay (1.9 vs 1.6 days) and incurred higher median costs (

Perioperative Outcomes of Robotic and Laparoscopic Simple Prostatectomy: A European-American Multi-institutional Analysis

12,754 vs

Stepwise Approach for Nerve Sparing Without Countertraction During Robot-Assisted Radical Prostatectomy: Technique and Outcomes

8,623, each p <0.01). CONCLUSIONS Demographic differences exist in robot-assisted laparoscopic radical prostatectomy patient populations between high and low volume hospitals. Higher volume hospitals showed fewer complications and lower costs than low volume hospitals on a national basis. These findings support referral to high volume centers for robot-assisted laparoscopic radical prostatectomy to decrease complications and costs.

Temporal Trends, Practice Patterns, and Treatment Outcomes for Infected Upper Urinary Tract Stones in the United States

IMPORTANCE There is limited data on the prevalence and mortality of venous thromboembolism (VTE) following oncologic surgery. OBJECTIVE To evaluate the trends, factors, and mortality of VTE following major cancer surgery. DESIGN, SETTING, AND PARTICIPANTS Patients undergoing colectomy, cystectomy, esophagectomy, gastrectomy, hysterectomy, lung resection, pancreatectomy, or prostatectomy were identified retrospectively using the Nationwide Inpatient Sample between January 1, 1999, and December 30, 2009, resulting in a weighted estimate of 2,508,916 patients. MAIN OUTCOMES AND MEASURES Venous thromboembolism following major cancer surgery was assessed according to date, patient, and hospital characteristics. The determinants of in-hospital VTE were evaluated using logistic regression analysis. RESULTS Venous thromboembolism showed an estimated annual percentage increase of 4.0% (95% CI, 2.9% to 5.1%), which contrasts with a 2.4% (95% CI, -4.3% to -0.5%) annual decrease in mortality in VTE after major cancer surgery. In multivariate logistic regression analysis, older age (odds ratio [OR], 1.03; P < .001), female sex (OR, 1.25; P < .001), black race (vs white; OR, 1.56; P < .001), Charlson comorbidity index score of 3 or more (OR, 1.85; P < .001), and Medicaid (vs private insurance; OR, 2.04; P < .001), Medicare (OR, 1.39; P < .001), and uninsured (OR, 1.49; P < .001) status were associated with an increased risk of VTE. Conversely, other (nonwhite and nonblack) race (OR, 0.75; P < .001) was associated with a lower risk of VTE. Among hospital characteristics, urban location (OR, 1.32; P < .001) and teaching status (OR, 1.08; P = .01) were associated with greater odds of VTE. Patients with vs without VTE experienced 5.3-fold greater odds of mortality. CONCLUSIONS AND RELEVANCE During our study period, VTE events following major cancer surgery increased in frequency; however, associated VTE mortality decreased. Changing VTE detection guidelines and better management of this condition may explain our findings.

The Impact of Prostate Size, Median Lobe, and Prior Benign Prostatic Hyperplasia Intervention on Robot-Assisted Laparoscopic Prostatectomy: Technique and Outcomes

BACKGROUND Laparoscopic and robotic simple prostatectomy (SP) have been introduced with the aim of reducing the morbidity of the standard open technique. OBJECTIVE To report a large multi-institutional series of minimally invasive SP (MISP). DESIGN, SETTING, AND PARTICIPANTS Consecutive cases of MISP done for the treatment of bladder outlet obstruction (BOO) due to benign prostatic enlargement (BPE) between 2000 and 2014 at 23 participating institutions in the Americas and Europe were included in this retrospective analysis. INTERVENTION Laparoscopic or robotic SP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Demographic data and main perioperative outcomes were gathered and analyzed. A multivariable analysis was conducted to identify factors associated with a favorable trifecta outcome, arbitrarily defined as a combination of the following postoperative events: International Prostate Symptom Score <8, maximum flow rate >15ml/s, and no perioperative complications. RESULTS AND LIMITATIONS Overall, 1330 consecutive cases were analyzed, including 487 robotic (36.6%) and 843 laparoscopic (63.4%) SP cases. Median overall prostate volume was 100ml (range: 89-128). Median estimated blood loss was 200ml (range: 150-300). An intraoperative transfusion was required in 3.5% of cases, an intraoperative complication was recorded in 2.2% of cases, and the conversion rate was 3%. Median length of stay was 4 d (range: 3-5). On pathology, prostate cancer was found in 4% of cases. Overall postoperative complication rate was 10.6%, mostly of low grade. At a median follow-up of 12 mo, a significant improvement was observed for subjective and objective indicators of BOO. Trifecta outcome was not significantly influenced by the type of procedure (robotic vs laparoscopic; p=0.136; odds ratio [OR]: 1.6; 95% confidence interval [CI], 0.8-2.9), whereas operative time (p=0.01; OR: 0.9; 95% CI, 0.9-1.0) and estimated blood loss (p=0.03; OR: 0.9; 95% CI, 0.9-1.0) were the only two significant factors. Retrospective study design, lack of a control arm, and limited follow-up represent major limitations of the present analysis. CONCLUSIONS This study provides the largest outcome analysis reported for MISP for BOO/BPE. These findings confirm that SP can be safely and effectively performed in a minimally invasive fashion in a variety of healthcare settings in which specific surgical expertise and technology is available. MISP can be considered a viable surgical treatment in cases of large prostatic adenomas. The use of robotic technology for this indication can be considered in centers that have a robotic program in place for other urologic indications. PATIENT SUMMARY Analysis of a large data set from multiple institutions shows that surgical removal of symptomatic large prostatic adenomas can be carried out with good outcomes by using robot-assisted laparoscopy.