- Email: [email protected]
Radical Prostatectomy in Austria From 1992 to 2009: An Updated Nationwide Analysis of 33,580 Cases
Radical Prostatectomy in Austria From 1992 to 2009: An Updated Nationwide Analysis of 33,580 Cases Clemens Wehrberger, Ingrid Berger, Manfred Willinger and Stephan Madersbacher* From the Department of Urology and Andrology, Donauspital and Austrian Health Institute (MW), Vienna, Austria
Abbreviations and Acronyms ÖBIG ⫽ Austrian Health Institute PCa ⫽ prostate cancer RPE ⫽ radical prostatectomy UI ⫽ urinary incontinence Submitted for publication September 13, 2011. Study received institutional review board approval. Supported by an unrestricted grant from AMS Deutschland, Niederlassung Österreich. * Correspondence: Department of Urology and Andrology, Donauspital, Langobardenstr. 122, A–1220 Vienna, Austria (telephone: ⫹⫹43-128802-3700; FAX: ⫹⫹43-1-28802-3780; e-mail: [email protected]).
Purpose: We analyzed the demographics and outcome of radical prostatectomy in Austria in a nationwide series. Materials and Methods: We analyzed the records of all 33,580 patients who underwent radical prostatectomy at a public hospital, including 95% of all surgical procedures, in Austria between 1992 and 2009. Patient demographics, perioperative mortality, interventions for anastomotic strictures and urinary incontinence, and overall survival were determined. Data were provided by the Austrian Health Institute. Results: The annual number of radical prostatectomies increased 688% from 396 in 1992 to 3,123 in 2007 and gradually decreased to 2,612 in 2009. Mean ⫾ SD patient age at surgery decreased slightly from 64.4 ⫾ 6.3 years in 1992 to 62.0 ⫾ 6.7 years in 2003. Age has remained at that level since then. Endourological intervention for anastomotic stricture and urinary incontinence was done in 7.5% and 2.8% of cases, respectively. The risk of each intervention increased with patient age and decreased in patients treated within the last 10 years compared to those treated before 2000. The 30-day mortality rate was 0.1%, which increased threefold from the youngest to the oldest age group. Ten-year overall survival decreased from 93% in patients 45 to 49 years old to 63% in those 70 years old or older at surgery. Conclusions: This nationwide analysis of a country that has had a public, equal access health care system for decades describes some current radical prostatectomy trends. Since 2007, the absolute number of radical prostatectomies has decreased. Data on morbidity, perioperative mortality and overall survival raise caution about performing radical prostatectomy in elderly men, eg those 70 years old or older. Key Words: prostate, prostatic neoplasms, aged, Austria, prostatectomy
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IN the last 2 decades RPE has become established as preferred treatment for men with localized PCa and life expectancy exceeding 10 years.1–3 RPE is the only curative treatment for PCa that has proven efficacy based on level I evidence.3– 6 Many large-scale series from centers of excellence have documented the favorable oncological and functional outcomes of this procedure.6 – 8 While oncological efficacy remains undisputed, particularly in younger men, the mor-
bidity of RPE is still of concern.6 – 8 Although a low morbidity rate has been consistently reported from centers of excellence, data generated on a broader basis suggest substantially higher morbidity.6 –10 Nationwide data would avoid the bias of reports from high volume surgeons or centers of excellence and, thus, would allow more realistic assessment. Since the late 1980s, all information on hospital admissions, diagnoses and interventions has been cen-
0022-5347/12/1875-1626/0 THE JOURNAL OF UROLOGY® © 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 187, 1626-1631, May 2012 Printed in U.S.A. DOI:10.1016/j.juro.2011.12.080
AND
RESEARCH, INC.
RADICAL PROSTATECTOMY IN AUSTRIA FROM 1992 TO 2009
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trally collected by ÖBIG. For decades Austria has had a public, equal access health care system with compulsory insurance coverage. In 2007 our group reported a nationwide analysis of RPE based on ÖBIG data on 16,524 patients from 1992 to 2003.11 In the current report we update that study until 2009, now including data on 33,580 patients treated with RPE. In this updated nationwide series we analyzed demographics, morbidity and survival in patients who underwent RPE in Austria.
PATIENTS AND METHODS In the current series we analyzed the records of all patients admitted to an Austrian public hospital between January 1, 1992 to December 31, 2009 with the diagnosis of PCa (ICD code C61) who underwent RPE regardless of any neoadjuvant or adjuvant therapy during this hospital stay. Data extracted from the ÖBIG database and included in analysis were date of operation, patient age at surgery, duration of hospital stay, readmission for anastomotic stricture (ICD code N35) with subsequent endoscopic treatment, readmission for UI (ICD code N39.3) with surgery for UI, and time and cause of death. Data on the age adjusted survival of the general population in Austria were obtained from Statistik Austria.12 Since this is a descriptive study, no formal statistical analysis was done.
RESULTS Patients A total of 33,580 patients underwent RPE between 1992 and 2009 at an Austrian public hospital. The annual number of RPEs increased from 396 in 1992 to 3,123 in 2007 and gradually decreased thereafter to 2,612 in 2009. The highest increase was detected in 60 to 69-year-old men, followed by those 50 to 59 years old (fig. 1).
Figure 1. Annual number of RPEs at public hospitals in Austria overall and by age groups, and mean hospital stay in days (d).
Figure 2. Age adjusted number of RPEs/100,000 inhabitants by age group.
The estimated total rate of RPEs/100,000 inhabitants increased from 21.9 in 1992 to 98.2 in 2000, and it was 110.3 in 2009. The highest values were found in 2004 (132.9) and 2007 (134.4) (fig. 2). With respect to the different age groups men 60 to 69 years old showed a sixfold increase in the operation incidence from 1992 to 2009 with the highest incidence of 423.6 RPEs/100,000 inhabitants in 2007 (fig. 2). The 50 to 59-year-old cohort had a peak incidence in 2004 of 170.9/100.000 inhabitants, representing an elevenfold increase (fig. 2). Mean age at surgery decreased slightly from 64.4 years in 1992 to 62.0 years in 2003 and remained stable in subsequent years. Figure 3 shows the age distribution at surgery during the study period. After 2002 there was a gradual increase in the percent of men 49 years old or younger treated with RPE from 0.8% in 1993 to 4% to 5% after 2003 (fig. 3). In parallel, we observed a constant decrease in the percent of the 70 year old or older cohort treated with surgery. In 1994 almost 25% of men were in this advanced age group. This proportion gradually decreased to 11% in 2005. However, beginning in 2005 there was again a slight
Figure 3. Age distribution of patients treated with RPE in Austria from 1992 to 2009.
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Figure 4. Patients who underwent surgery for UI and anastomotic/urethral stricture after RPE by age group.
increase in the proportion in the advanced age group to 13.7% in 2009. Mean hospital stay decreased from 22.8 days in 1992 to 11.4 in 2009 (fig. 1). Surgery for UI and Anastomotic Stricture Figure 4 shows the rate of surgery for UI and anastomotic/urethral stricture in different age groups. Overall 935 men (2.8%) underwent surgery for UI while 2,527 (7.5%) required endourological intervention for anastomotic/urethral stricture. The risk of surgery for UI increased fivefold from ages less than 50 vs 70 to 74 years. The rate of incontinence surgery was 2% or less in men younger than 60 years but it increased to 4% in the population 70 years old or older. A similar trend was observed for endourological intervention for anastomotic/urethral stricture. The risk doubled from around 5% in men younger than 60 years to 10% in those older than 70 years (fig. 4). The rate of surgery for UI and anastomotic/urethral stricture decreased substantially in men treated in the last decade. While almost 15% of those operated on in the early 1990s required surgery for anastomotic stricture, this decreased to less than 5% in those operated on in the most recent years. A similar but less profound trend was observed for surgery for UI (fig. 5). Perioperative Mortality and Overall Survival Within the first 30 days after surgery 34 patients died, resulting in 0.1% overall perioperative mortality. In 24 cases PCa was recorded as the cause of death. In these cases it is likely that the cause for death could not be identified or was misrecorded. In the remaining 10 patients cardiovascular disease, mainly pulmonary embolism, myocardial infarction and stroke, was recorded as the cause of death. Perioperative mortality occurred in 7 of 10,180 patients (0.069%) younger than 60 years at surgery, in
Figure 5. Patients who underwent surgery for UI and anastomotic/urethral stricture after RPE with time from 1992 to 2007.
18 of 18,642 (0.097%) 60 to 69 years old and in 9 of 4,758 (0.19%) older than 70 years. The 30-day mortality was 0.26% to 0.42% between 1992 and 1997, and 0.05% to 0.15% between 1998 and 2009. In 1992, 1997 and 2007 no deaths were documented in the first 30 days after surgery. Figure 6 shows overall survival in the age groups. Since the study period started in 1992, maximum followup was 18 years. These data reveal excellent intermediate and long-term survival after RPE. Ten-year overall survival was 93% at ages 45 to 49 years, 89% at 50 to 54, 86% at 55 to 59, 82% at 60 to 64, 80% at 65 to 69, 80% at 70 to 74 and 63% in the oldest age group of 75 years or greater. These values were almost identical to those of the general male population in our country. According to Statistik Austria in our country 5-year survival was 95.8% to 95.9% in men 50 to 59 years old, 90.3% to 90.8% in those 60 to 69 years old and 75.3% to 78.0% in those 70 to 79 years old.12 Overall PCa was the cause of death in 12.4% of all patients. This rate decreased gradually from 14% in men younger than 54 years to 9.8% in the population 70 years old or older.
Figure 6. Overall survival after RPE by age group
RADICAL PROSTATECTOMY IN AUSTRIA FROM 1992 TO 2009
DISCUSSION Since the late 1980s, ÖBIG has collected information on hospital admissions, which enabled our nationwide analysis. As indicated, this study represents an update of a series published in 2007 based on 16,524 patients.11 This update now contains data on 33,580 patients. Austria is one of the few countries where nationwide health related data are available. Our study has certain strengths. 1) This represents one of the few nationwide series with a large sample size. 2) For decades Austria has had a public, equal access health care system with compulsory insurance coverage. Thus, these data are not biased, eg by insurance status. 3) Due to the nationwide registry the rate of loss to followup is small and only occurs if a patient has moved abroad. Several study limitations must also be considered. 1) Patients operated on at a private hospital were not included in analysis. Fewer than 5% of all patients in Austria are operated on in this setting. 2) Histological data were not available since it was not allowed to match the ÖBIG database with the Austrian National Cancer Registry. 3) Our analysis was limited to data entered into the ÖBIG database. More detailed data, eg on preoperative prostate specific antigen, transfusion rate, degree of erectile dysfunction (eg International Index of Erectile Function-5 or phosphodiesterase-5 inhibitor use), UI (eg pad use), etc were not available. 4) No data were available on RPE type. However, even in 2009 the open retropubic approach accounted for two-thirds of cases in Austria and to date only 4 institutions are equipped with a da Vinci® device.12 In the last decade PCa related mortality decreased continuously due to prostate specific antigen testing, widespread screening and identification of tumors at an early stage in many countries, including Austria.13,14 Nevertheless, incidence and mortality rates vary substantially in different countries.15–17 Similar to other industrialized countries, we observed a dramatic, almost sevenfold increase in the annual number of RPEs in the last 18 years. Surgical volume peaked between 2004 and 2007, and decreased slightly thereafter. The number of RPEs in Austria (1,179) during the first 6 months of 2010 suggests a further decrease in the number of RPEs performed. This decrease was most likely due to several factors, including the increased popularity of nonoperative approaches such as brachytherapy and active surveillance, less aggressive biopsy strategies and widespread opportunistic screening for 15 years, which resulted in the recent decrease in the PCa incidence in Austria. Currently information is sparse on similar population based, nationwide studies of this issue.
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Age distribution at surgery decreased in terms of the proportion of elderly men treated with surgery from the early 1990s until 2005. Thereafter we observed a slight increase in the proportion of elderly men treated with surgery. The reason for this trend remains speculative. One might assume that the decrease in the absolute number of RPEs was compensated for by a more liberal approach to surgery. Alternatively this observation may be driven by constantly increasing life expectancy. The proportion of the youngest age group (less than 49 years) increased from less than 1% in the early 1990s to around 4% in 2003 to 2009, without doubt due to widespread opportunistic screening in Austria. Hospital stay decreased constantly to around 11 days in 2009. The duration of hospitalization was substantially greater, as in other countries, particularly compared to statistics in the United States and United Kingdom.18 This is due to the Austrian reimbursement and health care system. Several reports document the impact of surgical volume on morbidity, functional and oncological outcome.19,20 Currently at high volume centers in our country about 80 to 180 RPEs are done annually. This number is low compared to that at international high volume centers. As emphasized in our previous report,11 it is not legally allowed to break down the ÖBIG database by individual centers. Thus, we could not correlate the impact of surgical volume on outcome. The major advantage of a nationwide analysis is to determine RPE morbidity throughout a country.16 In fact, there exists a considerable discrepancy regarding, for instance, the degree of UI after RPE with usually low rates at centers of excellence (continence rate 95% or even higher) and higher rates according to patient directed analysis and Medicare data.11–13,19,20 The ÖBIG database contains no information on the degree of postoperative UI, such as the number of pads used, but data on surgery for UI were available. Overall 2.8% of patients were treated with surgery for UI and age had a significant impact (fig. 4). The incidence was less than 1% in younger age groups, which increased up to 3% to 4% in the cohort 70 years old or older (fig. 4). Several groups have documented the impact of age on morbidity and functional outcome after RPE.21–24 Kerr and Zincke observed a significantly higher rate of UI 1 year after RPE in men 75 years old or older than in men 55 years old or younger (16% vs 3%).21 Nilsson et al analyzed the records of 1,411 patients who underwent open or robotassisted laparoscopic RPE between 2002 and 2006.22 Of the oldest patients 19% experienced UI compared to 6% in the youngest age group. The rela-
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tive annual increase in UI was 6%. Similar observations have been noted, eg by Novara et al in 308 patients who underwent robot-assisted laparoscopic RPE.25 The most common surgical intervention after RPE is for anastomotic stricture. In our population 8.5% of patients underwent endourological intervention for anastomotic stricture with a substantial decrease in those operated on in more recent years (fig. 4). Generally these data are favorable, eg compared to Medicare reports, and they are in the range of data from centers of excellence. The impact of a nationwide learning curve and improved surgical technique, particularly for apical dissection and anastomotic technique, is impressively documented by the decreasing rate of surgery for anastomotic stricture and UI depending on the year of surgery (fig. 5). Perioperative nationwide mortality in our series was acceptable at 0.1% and within the range of other large-scale studies.26 Despite low absolute numbers perioperative mortality increased almost threefold from the youngest group (less than 60 years) to the oldest age group (70 or greater years, 0.19%). Alibhai et al evaluated 30-day mortality using the Ontario Cancer registry.26 In this database of 11,010 men greater early mortality was reported (0.5%). As in our series, the major causes of recorded death
were cardiovascular disease and pulmonary embolism. The higher perioperative mortality than in our data might have been due to the higher mean age of 68 years in the Canadian series.25 The overall survival after RPE in Austria was excellent. Ten-years overall survival in the age groups was 93% at ages 45 to 49 years, 89% at 50 to 54, 86% at 55 to 59, 82% at 60 to 64, 80% at 65 to 69, 80% at 70 to 74 and 63% in the oldest age group of 75 or greater. These survival data are comparable to the overall survival of the general male population in our country. The Mayo Clinic group presented long-term data on 5,509 RPEs done between 1987 and 1995.27 Tenyear survival in the age groups was in accord with our data, including 92% at ages less than 55 years, 90% at 55 to 59, 88% at 60 to 64, 83% at 65 to 69 and 74% at 70 or greater.
CONCLUSIONS This analysis provides an overview of the RPE trend during the last 17 years. RPE perioperative mortality was low, the total incontinence rate was acceptable, and overall midterm survival at 5 to 10 years was excellent and equal to that of the age matched general population in Austria. Age is a crucial factor for perioperative mortality, postoperative morbidity and overall survival.
REFERENCES 1. Walsh PC: Anatomic radical prostatectomy: evolution of the surgical technique. J Urol 1998; 160: 2418. 2. Ficarra V, Novara G, Artibani W et al: Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol 2009; 55: 1037. 3. Heidenreich A, Aus G, Bolla M et al: EAU guidelines on prostate cancer. Eur Urol 2008; 53: 68. 4. Bill-Axelson A, Holmberg L, Ruutu M et al: Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2005; 352: 1977. 5. Bill-Axelson A, Holmberg L, Ruutu M et al: Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2011; 364: 1708. 6. Graefen M, Walz J and Huland H: Open retropubic nerve-sparing radical prostatectomy. Eur Urol 2006; 49: 38. 7. Boorjian SA, Karnes RJ, Viterbo R et al: Longterm survival after radical prostatectomy versus external-beam radiotherapy for patients with
high-risk prostate cancer. Cancer 2011; 117: 2883. 8. Menon M, Shrivastava A, Kaul S et al: Vattikuti Institute prostatectomy: contemporary technique and analysis of results. Eur Urol 2007; 51: 648. 9. Benoit RM, Naslund MJ and Cohen JK: Complications after radical retropubic prostatectomy in the Medicare population. Urology 2000; 56: 116. 10. Sebesta M, Cespedes RD, Luhman E et al: Questionnaire-based outcomes of urinary incontinence and satisfaction rates after radical prostatectomy in a national study population. Urology 2002; 60: 1055. 11. Mohamad BA, Marszalek M, Brössner C et al: Radical prostatectomy in Austria: a nation-wide analysis of 16.524 cases. Eur Urol 2007; 51: 684. 12. Gesundheit. Statistik Austria. Available at http:// www.stat.at/web_de/statistiken/gesundheit/index. html. Accessed September 2011. 13. Grönberg H: Prostate cancer epidemiology. Lancet 2003; 361: 859. 14. Brawley OW and Barnes S: The epidemiology of prostate cancer in the United States. Semin Oncol Nurs 2001; 17: 72.
15. Boyle P, Severi G and Giles GG: The epidemiology of prostate cancer. Urol Clin North Am 2003; 30: 209. 16. Barnholtz-Sloan JS, Severson RK, Vaishampayan U et al: Survival analysis of distant prostate cancer by decade (1973-1997) in Detroit Metropolitan Surveillance, Epidemiology and End Results (SEER) Program registry: has outcome improved? (United States). Cancer Causes Control 2003; 14: 681. 17. Cetin K, Beebe-Dimmer JL, Fryzek JP et al: Recent time trends in the epidemiology of stage IV prostate cancer in the United States: analysis of the data from the Surveillance, Epidemiology and End-Result Program. Urology 2010; 75: 1396. 18. Hanchanale VS, McCabe JE and Javlé P: Radical prostatectomy practice in England. Urol J 2010; 7: 243. 19. Begg CB, Riedel ER, Bach PB et al: Variations in morbidity after radical prostatectomy. N Engl J Med 2002; 346: 1138. 20. Vesey SG, McCabe JE, Hounsome L et al: UK radical prostatectomy outcomes and surgeon case volume: based on an analysis of the British Association of Urological Surgeons Complex Operations Database. BJU Int 2011; 109: 346.
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21. Kerr LA and Zincke H: Radical retropubic prostatectomy for prostate cancer in the elderly and the young: complications and prognosis. Eur Urol 1994; 25: 305.
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an interim analysis of results and technical points. Urology, suppl., 2003; 61: 15.
scopic radical prostatectomy. J Urol 2010; 184: 1028.
22. Nilsson AE, Schumacher MC, Johansson E et al: Age at surgery, educational and long-term urinary incontinence after radical prostatectomy. BJU Int 2011; 108: 1572.
24. Karakiewicz PI, Tanguay S, Kattan MW et al: Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men. Eur Urol 2004; 46: 188.
26. Alibhai SMH, Leach M and Tomlinson G: Examining the location and cause of death within 30 days after radical prostatectomy. BJU Int 2005; 95: 541.
23. Menon M, Tewari A and the Vattikuti Institute Prostatectomy Team: Robotic radical prostatectomy and the Vattikuti Urology Institute technique:
25. Novara G, Ficarra V, D’elia C et al: Evaluating urinary continence and preoperative predictors of urinary continence after robot assisted laparo-
27. Siddiqui SS, Sengupta S, Slezak JM et al: Impact of patient age at treatment on outcome following radical retropubic prostatectomy for prostate cancer. J Urol 2006; 175: 952.
EDITORIAL COMMENT These authors describe a large group of men treated with RPE at 28 smaller centers in a small nation. Results show a decrease with time in the rate of 2 complications that could be considered technical in nature, namely incontinence and bladder neck contracture requiring surgical correction. There are 2 points to glean from this. 1) Using national data the impact at busy centers of excellence is smoothed out and a realistic picture of RPE can be ascertained. 2) The data present a good picture of what can be
accomplished with time by dedicated surgeons to decrease technical complications even at small centers. Urology would benefit from more studies of national and regional databases to obtain a broad picture of the representative results of many procedures. James M. Cummings Division of Urology University of Missouri Columbia, Missouri
Abbreviations and Acronyms ÖBIG ⫽ Austrian Health Institute PCa ⫽ prostate cancer RPE ⫽ radical prostatectomy UI ⫽ urinary incontinence Submitted for publication September 13, 2011. Study received institutional review board approval. Supported by an unrestricted grant from AMS Deutschland, Niederlassung Österreich. * Correspondence: Department of Urology and Andrology, Donauspital, Langobardenstr. 122, A–1220 Vienna, Austria (telephone: ⫹⫹43-128802-3700; FAX: ⫹⫹43-1-28802-3780; e-mail: [email protected]).
Purpose: We analyzed the demographics and outcome of radical prostatectomy in Austria in a nationwide series. Materials and Methods: We analyzed the records of all 33,580 patients who underwent radical prostatectomy at a public hospital, including 95% of all surgical procedures, in Austria between 1992 and 2009. Patient demographics, perioperative mortality, interventions for anastomotic strictures and urinary incontinence, and overall survival were determined. Data were provided by the Austrian Health Institute. Results: The annual number of radical prostatectomies increased 688% from 396 in 1992 to 3,123 in 2007 and gradually decreased to 2,612 in 2009. Mean ⫾ SD patient age at surgery decreased slightly from 64.4 ⫾ 6.3 years in 1992 to 62.0 ⫾ 6.7 years in 2003. Age has remained at that level since then. Endourological intervention for anastomotic stricture and urinary incontinence was done in 7.5% and 2.8% of cases, respectively. The risk of each intervention increased with patient age and decreased in patients treated within the last 10 years compared to those treated before 2000. The 30-day mortality rate was 0.1%, which increased threefold from the youngest to the oldest age group. Ten-year overall survival decreased from 93% in patients 45 to 49 years old to 63% in those 70 years old or older at surgery. Conclusions: This nationwide analysis of a country that has had a public, equal access health care system for decades describes some current radical prostatectomy trends. Since 2007, the absolute number of radical prostatectomies has decreased. Data on morbidity, perioperative mortality and overall survival raise caution about performing radical prostatectomy in elderly men, eg those 70 years old or older. Key Words: prostate, prostatic neoplasms, aged, Austria, prostatectomy
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IN the last 2 decades RPE has become established as preferred treatment for men with localized PCa and life expectancy exceeding 10 years.1–3 RPE is the only curative treatment for PCa that has proven efficacy based on level I evidence.3– 6 Many large-scale series from centers of excellence have documented the favorable oncological and functional outcomes of this procedure.6 – 8 While oncological efficacy remains undisputed, particularly in younger men, the mor-
bidity of RPE is still of concern.6 – 8 Although a low morbidity rate has been consistently reported from centers of excellence, data generated on a broader basis suggest substantially higher morbidity.6 –10 Nationwide data would avoid the bias of reports from high volume surgeons or centers of excellence and, thus, would allow more realistic assessment. Since the late 1980s, all information on hospital admissions, diagnoses and interventions has been cen-
0022-5347/12/1875-1626/0 THE JOURNAL OF UROLOGY® © 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 187, 1626-1631, May 2012 Printed in U.S.A. DOI:10.1016/j.juro.2011.12.080
AND
RESEARCH, INC.
RADICAL PROSTATECTOMY IN AUSTRIA FROM 1992 TO 2009
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trally collected by ÖBIG. For decades Austria has had a public, equal access health care system with compulsory insurance coverage. In 2007 our group reported a nationwide analysis of RPE based on ÖBIG data on 16,524 patients from 1992 to 2003.11 In the current report we update that study until 2009, now including data on 33,580 patients treated with RPE. In this updated nationwide series we analyzed demographics, morbidity and survival in patients who underwent RPE in Austria.
PATIENTS AND METHODS In the current series we analyzed the records of all patients admitted to an Austrian public hospital between January 1, 1992 to December 31, 2009 with the diagnosis of PCa (ICD code C61) who underwent RPE regardless of any neoadjuvant or adjuvant therapy during this hospital stay. Data extracted from the ÖBIG database and included in analysis were date of operation, patient age at surgery, duration of hospital stay, readmission for anastomotic stricture (ICD code N35) with subsequent endoscopic treatment, readmission for UI (ICD code N39.3) with surgery for UI, and time and cause of death. Data on the age adjusted survival of the general population in Austria were obtained from Statistik Austria.12 Since this is a descriptive study, no formal statistical analysis was done.
RESULTS Patients A total of 33,580 patients underwent RPE between 1992 and 2009 at an Austrian public hospital. The annual number of RPEs increased from 396 in 1992 to 3,123 in 2007 and gradually decreased thereafter to 2,612 in 2009. The highest increase was detected in 60 to 69-year-old men, followed by those 50 to 59 years old (fig. 1).
Figure 1. Annual number of RPEs at public hospitals in Austria overall and by age groups, and mean hospital stay in days (d).
Figure 2. Age adjusted number of RPEs/100,000 inhabitants by age group.
The estimated total rate of RPEs/100,000 inhabitants increased from 21.9 in 1992 to 98.2 in 2000, and it was 110.3 in 2009. The highest values were found in 2004 (132.9) and 2007 (134.4) (fig. 2). With respect to the different age groups men 60 to 69 years old showed a sixfold increase in the operation incidence from 1992 to 2009 with the highest incidence of 423.6 RPEs/100,000 inhabitants in 2007 (fig. 2). The 50 to 59-year-old cohort had a peak incidence in 2004 of 170.9/100.000 inhabitants, representing an elevenfold increase (fig. 2). Mean age at surgery decreased slightly from 64.4 years in 1992 to 62.0 years in 2003 and remained stable in subsequent years. Figure 3 shows the age distribution at surgery during the study period. After 2002 there was a gradual increase in the percent of men 49 years old or younger treated with RPE from 0.8% in 1993 to 4% to 5% after 2003 (fig. 3). In parallel, we observed a constant decrease in the percent of the 70 year old or older cohort treated with surgery. In 1994 almost 25% of men were in this advanced age group. This proportion gradually decreased to 11% in 2005. However, beginning in 2005 there was again a slight
Figure 3. Age distribution of patients treated with RPE in Austria from 1992 to 2009.
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Figure 4. Patients who underwent surgery for UI and anastomotic/urethral stricture after RPE by age group.
increase in the proportion in the advanced age group to 13.7% in 2009. Mean hospital stay decreased from 22.8 days in 1992 to 11.4 in 2009 (fig. 1). Surgery for UI and Anastomotic Stricture Figure 4 shows the rate of surgery for UI and anastomotic/urethral stricture in different age groups. Overall 935 men (2.8%) underwent surgery for UI while 2,527 (7.5%) required endourological intervention for anastomotic/urethral stricture. The risk of surgery for UI increased fivefold from ages less than 50 vs 70 to 74 years. The rate of incontinence surgery was 2% or less in men younger than 60 years but it increased to 4% in the population 70 years old or older. A similar trend was observed for endourological intervention for anastomotic/urethral stricture. The risk doubled from around 5% in men younger than 60 years to 10% in those older than 70 years (fig. 4). The rate of surgery for UI and anastomotic/urethral stricture decreased substantially in men treated in the last decade. While almost 15% of those operated on in the early 1990s required surgery for anastomotic stricture, this decreased to less than 5% in those operated on in the most recent years. A similar but less profound trend was observed for surgery for UI (fig. 5). Perioperative Mortality and Overall Survival Within the first 30 days after surgery 34 patients died, resulting in 0.1% overall perioperative mortality. In 24 cases PCa was recorded as the cause of death. In these cases it is likely that the cause for death could not be identified or was misrecorded. In the remaining 10 patients cardiovascular disease, mainly pulmonary embolism, myocardial infarction and stroke, was recorded as the cause of death. Perioperative mortality occurred in 7 of 10,180 patients (0.069%) younger than 60 years at surgery, in
Figure 5. Patients who underwent surgery for UI and anastomotic/urethral stricture after RPE with time from 1992 to 2007.
18 of 18,642 (0.097%) 60 to 69 years old and in 9 of 4,758 (0.19%) older than 70 years. The 30-day mortality was 0.26% to 0.42% between 1992 and 1997, and 0.05% to 0.15% between 1998 and 2009. In 1992, 1997 and 2007 no deaths were documented in the first 30 days after surgery. Figure 6 shows overall survival in the age groups. Since the study period started in 1992, maximum followup was 18 years. These data reveal excellent intermediate and long-term survival after RPE. Ten-year overall survival was 93% at ages 45 to 49 years, 89% at 50 to 54, 86% at 55 to 59, 82% at 60 to 64, 80% at 65 to 69, 80% at 70 to 74 and 63% in the oldest age group of 75 years or greater. These values were almost identical to those of the general male population in our country. According to Statistik Austria in our country 5-year survival was 95.8% to 95.9% in men 50 to 59 years old, 90.3% to 90.8% in those 60 to 69 years old and 75.3% to 78.0% in those 70 to 79 years old.12 Overall PCa was the cause of death in 12.4% of all patients. This rate decreased gradually from 14% in men younger than 54 years to 9.8% in the population 70 years old or older.
Figure 6. Overall survival after RPE by age group
RADICAL PROSTATECTOMY IN AUSTRIA FROM 1992 TO 2009
DISCUSSION Since the late 1980s, ÖBIG has collected information on hospital admissions, which enabled our nationwide analysis. As indicated, this study represents an update of a series published in 2007 based on 16,524 patients.11 This update now contains data on 33,580 patients. Austria is one of the few countries where nationwide health related data are available. Our study has certain strengths. 1) This represents one of the few nationwide series with a large sample size. 2) For decades Austria has had a public, equal access health care system with compulsory insurance coverage. Thus, these data are not biased, eg by insurance status. 3) Due to the nationwide registry the rate of loss to followup is small and only occurs if a patient has moved abroad. Several study limitations must also be considered. 1) Patients operated on at a private hospital were not included in analysis. Fewer than 5% of all patients in Austria are operated on in this setting. 2) Histological data were not available since it was not allowed to match the ÖBIG database with the Austrian National Cancer Registry. 3) Our analysis was limited to data entered into the ÖBIG database. More detailed data, eg on preoperative prostate specific antigen, transfusion rate, degree of erectile dysfunction (eg International Index of Erectile Function-5 or phosphodiesterase-5 inhibitor use), UI (eg pad use), etc were not available. 4) No data were available on RPE type. However, even in 2009 the open retropubic approach accounted for two-thirds of cases in Austria and to date only 4 institutions are equipped with a da Vinci® device.12 In the last decade PCa related mortality decreased continuously due to prostate specific antigen testing, widespread screening and identification of tumors at an early stage in many countries, including Austria.13,14 Nevertheless, incidence and mortality rates vary substantially in different countries.15–17 Similar to other industrialized countries, we observed a dramatic, almost sevenfold increase in the annual number of RPEs in the last 18 years. Surgical volume peaked between 2004 and 2007, and decreased slightly thereafter. The number of RPEs in Austria (1,179) during the first 6 months of 2010 suggests a further decrease in the number of RPEs performed. This decrease was most likely due to several factors, including the increased popularity of nonoperative approaches such as brachytherapy and active surveillance, less aggressive biopsy strategies and widespread opportunistic screening for 15 years, which resulted in the recent decrease in the PCa incidence in Austria. Currently information is sparse on similar population based, nationwide studies of this issue.
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Age distribution at surgery decreased in terms of the proportion of elderly men treated with surgery from the early 1990s until 2005. Thereafter we observed a slight increase in the proportion of elderly men treated with surgery. The reason for this trend remains speculative. One might assume that the decrease in the absolute number of RPEs was compensated for by a more liberal approach to surgery. Alternatively this observation may be driven by constantly increasing life expectancy. The proportion of the youngest age group (less than 49 years) increased from less than 1% in the early 1990s to around 4% in 2003 to 2009, without doubt due to widespread opportunistic screening in Austria. Hospital stay decreased constantly to around 11 days in 2009. The duration of hospitalization was substantially greater, as in other countries, particularly compared to statistics in the United States and United Kingdom.18 This is due to the Austrian reimbursement and health care system. Several reports document the impact of surgical volume on morbidity, functional and oncological outcome.19,20 Currently at high volume centers in our country about 80 to 180 RPEs are done annually. This number is low compared to that at international high volume centers. As emphasized in our previous report,11 it is not legally allowed to break down the ÖBIG database by individual centers. Thus, we could not correlate the impact of surgical volume on outcome. The major advantage of a nationwide analysis is to determine RPE morbidity throughout a country.16 In fact, there exists a considerable discrepancy regarding, for instance, the degree of UI after RPE with usually low rates at centers of excellence (continence rate 95% or even higher) and higher rates according to patient directed analysis and Medicare data.11–13,19,20 The ÖBIG database contains no information on the degree of postoperative UI, such as the number of pads used, but data on surgery for UI were available. Overall 2.8% of patients were treated with surgery for UI and age had a significant impact (fig. 4). The incidence was less than 1% in younger age groups, which increased up to 3% to 4% in the cohort 70 years old or older (fig. 4). Several groups have documented the impact of age on morbidity and functional outcome after RPE.21–24 Kerr and Zincke observed a significantly higher rate of UI 1 year after RPE in men 75 years old or older than in men 55 years old or younger (16% vs 3%).21 Nilsson et al analyzed the records of 1,411 patients who underwent open or robotassisted laparoscopic RPE between 2002 and 2006.22 Of the oldest patients 19% experienced UI compared to 6% in the youngest age group. The rela-
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RADICAL PROSTATECTOMY IN AUSTRIA FROM 1992 TO 2009
tive annual increase in UI was 6%. Similar observations have been noted, eg by Novara et al in 308 patients who underwent robot-assisted laparoscopic RPE.25 The most common surgical intervention after RPE is for anastomotic stricture. In our population 8.5% of patients underwent endourological intervention for anastomotic stricture with a substantial decrease in those operated on in more recent years (fig. 4). Generally these data are favorable, eg compared to Medicare reports, and they are in the range of data from centers of excellence. The impact of a nationwide learning curve and improved surgical technique, particularly for apical dissection and anastomotic technique, is impressively documented by the decreasing rate of surgery for anastomotic stricture and UI depending on the year of surgery (fig. 5). Perioperative nationwide mortality in our series was acceptable at 0.1% and within the range of other large-scale studies.26 Despite low absolute numbers perioperative mortality increased almost threefold from the youngest group (less than 60 years) to the oldest age group (70 or greater years, 0.19%). Alibhai et al evaluated 30-day mortality using the Ontario Cancer registry.26 In this database of 11,010 men greater early mortality was reported (0.5%). As in our series, the major causes of recorded death
were cardiovascular disease and pulmonary embolism. The higher perioperative mortality than in our data might have been due to the higher mean age of 68 years in the Canadian series.25 The overall survival after RPE in Austria was excellent. Ten-years overall survival in the age groups was 93% at ages 45 to 49 years, 89% at 50 to 54, 86% at 55 to 59, 82% at 60 to 64, 80% at 65 to 69, 80% at 70 to 74 and 63% in the oldest age group of 75 or greater. These survival data are comparable to the overall survival of the general male population in our country. The Mayo Clinic group presented long-term data on 5,509 RPEs done between 1987 and 1995.27 Tenyear survival in the age groups was in accord with our data, including 92% at ages less than 55 years, 90% at 55 to 59, 88% at 60 to 64, 83% at 65 to 69 and 74% at 70 or greater.
CONCLUSIONS This analysis provides an overview of the RPE trend during the last 17 years. RPE perioperative mortality was low, the total incontinence rate was acceptable, and overall midterm survival at 5 to 10 years was excellent and equal to that of the age matched general population in Austria. Age is a crucial factor for perioperative mortality, postoperative morbidity and overall survival.
REFERENCES 1. Walsh PC: Anatomic radical prostatectomy: evolution of the surgical technique. J Urol 1998; 160: 2418. 2. Ficarra V, Novara G, Artibani W et al: Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol 2009; 55: 1037. 3. Heidenreich A, Aus G, Bolla M et al: EAU guidelines on prostate cancer. Eur Urol 2008; 53: 68. 4. Bill-Axelson A, Holmberg L, Ruutu M et al: Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2005; 352: 1977. 5. Bill-Axelson A, Holmberg L, Ruutu M et al: Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2011; 364: 1708. 6. Graefen M, Walz J and Huland H: Open retropubic nerve-sparing radical prostatectomy. Eur Urol 2006; 49: 38. 7. Boorjian SA, Karnes RJ, Viterbo R et al: Longterm survival after radical prostatectomy versus external-beam radiotherapy for patients with
high-risk prostate cancer. Cancer 2011; 117: 2883. 8. Menon M, Shrivastava A, Kaul S et al: Vattikuti Institute prostatectomy: contemporary technique and analysis of results. Eur Urol 2007; 51: 648. 9. Benoit RM, Naslund MJ and Cohen JK: Complications after radical retropubic prostatectomy in the Medicare population. Urology 2000; 56: 116. 10. Sebesta M, Cespedes RD, Luhman E et al: Questionnaire-based outcomes of urinary incontinence and satisfaction rates after radical prostatectomy in a national study population. Urology 2002; 60: 1055. 11. Mohamad BA, Marszalek M, Brössner C et al: Radical prostatectomy in Austria: a nation-wide analysis of 16.524 cases. Eur Urol 2007; 51: 684. 12. Gesundheit. Statistik Austria. Available at http:// www.stat.at/web_de/statistiken/gesundheit/index. html. Accessed September 2011. 13. Grönberg H: Prostate cancer epidemiology. Lancet 2003; 361: 859. 14. Brawley OW and Barnes S: The epidemiology of prostate cancer in the United States. Semin Oncol Nurs 2001; 17: 72.
15. Boyle P, Severi G and Giles GG: The epidemiology of prostate cancer. Urol Clin North Am 2003; 30: 209. 16. Barnholtz-Sloan JS, Severson RK, Vaishampayan U et al: Survival analysis of distant prostate cancer by decade (1973-1997) in Detroit Metropolitan Surveillance, Epidemiology and End Results (SEER) Program registry: has outcome improved? (United States). Cancer Causes Control 2003; 14: 681. 17. Cetin K, Beebe-Dimmer JL, Fryzek JP et al: Recent time trends in the epidemiology of stage IV prostate cancer in the United States: analysis of the data from the Surveillance, Epidemiology and End-Result Program. Urology 2010; 75: 1396. 18. Hanchanale VS, McCabe JE and Javlé P: Radical prostatectomy practice in England. Urol J 2010; 7: 243. 19. Begg CB, Riedel ER, Bach PB et al: Variations in morbidity after radical prostatectomy. N Engl J Med 2002; 346: 1138. 20. Vesey SG, McCabe JE, Hounsome L et al: UK radical prostatectomy outcomes and surgeon case volume: based on an analysis of the British Association of Urological Surgeons Complex Operations Database. BJU Int 2011; 109: 346.
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21. Kerr LA and Zincke H: Radical retropubic prostatectomy for prostate cancer in the elderly and the young: complications and prognosis. Eur Urol 1994; 25: 305.
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an interim analysis of results and technical points. Urology, suppl., 2003; 61: 15.
scopic radical prostatectomy. J Urol 2010; 184: 1028.
22. Nilsson AE, Schumacher MC, Johansson E et al: Age at surgery, educational and long-term urinary incontinence after radical prostatectomy. BJU Int 2011; 108: 1572.
24. Karakiewicz PI, Tanguay S, Kattan MW et al: Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men. Eur Urol 2004; 46: 188.
26. Alibhai SMH, Leach M and Tomlinson G: Examining the location and cause of death within 30 days after radical prostatectomy. BJU Int 2005; 95: 541.
23. Menon M, Tewari A and the Vattikuti Institute Prostatectomy Team: Robotic radical prostatectomy and the Vattikuti Urology Institute technique:
25. Novara G, Ficarra V, D’elia C et al: Evaluating urinary continence and preoperative predictors of urinary continence after robot assisted laparo-
27. Siddiqui SS, Sengupta S, Slezak JM et al: Impact of patient age at treatment on outcome following radical retropubic prostatectomy for prostate cancer. J Urol 2006; 175: 952.
EDITORIAL COMMENT These authors describe a large group of men treated with RPE at 28 smaller centers in a small nation. Results show a decrease with time in the rate of 2 complications that could be considered technical in nature, namely incontinence and bladder neck contracture requiring surgical correction. There are 2 points to glean from this. 1) Using national data the impact at busy centers of excellence is smoothed out and a realistic picture of RPE can be ascertained. 2) The data present a good picture of what can be
accomplished with time by dedicated surgeons to decrease technical complications even at small centers. Urology would benefit from more studies of national and regional databases to obtain a broad picture of the representative results of many procedures. James M. Cummings Division of Urology University of Missouri Columbia, Missouri