EUROPEAN UROLOGY 67 (2015) 1063–1065
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 1056–1062 of this issue
Mortality Following Radical Cystectomy: A Good Start, but How Low Can We Go? Derek J. Rosario * Department of Oncology, Faculty of Medicine and Dentistry, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK
In this issue of European Urology, Hounsome and colleagues [1] describe improving outcomes following radical cystectomy (RC) in England between 1998 and 2010, suggesting neoadjuvant chemotherapy (NAC), centralisation, enhanced recovery protocols (enhanced recovery after surgery, ERAS), and fellowship training as contributors. The authors are to be congratulated on such a thorough analysis; however, as with any retrospective output of an administrative database, confounding variables cannot be allowed for, so uncertainties remain as to the conclusions. This has been acknowledged in the manuscript, but the overall contribution to the literature warrants further comment. Given an absolute reduction in 90-d mortality of 5%, improvement in surgical care seems to be mostly responsible rather than NAC, particularly in the general setting of low NAC uptake [2]. Similarly, reports of reduced perioperative mortality preceded centralisation [3], which casts some doubt as to the efficacy of the centralisation enforced by the National Institute of Clinical Excellence Improving Outcomes Guidance. There is little evidence supporting the notion that ERAS protocols reduce perioperative mortality. Training is indeed essential, and I return to this later. Assuming a basic level of care provision, three features determine perioperative mortality: (1) patient selection, (2) operative competence (including anaesthetic administration), and (3) the effectiveness of retrieval strategies when adverse events occur; each of these is influenced in turn by the surgeon’s expertise, the institutional caseload, and the overall health care resource. Both surgeon and institutional case-volumes matter, but optimal levels are contentious. Minimum surgeon volumes of eight [4] and 10 RCs per annum [5] have been suggested,
the former against high overall inpatient mortality of 5.6%. The evidence that institutional volume affects outcome is strong but variable; Birkmeyer et al [6] observed reduced mortality at a level of >11 RCs (Table 1A), whereas Barbieri et al [7] suggested that 50 RCs per annum were associated with the best outcomes. Kulkarni et al [8] found no significant impact of institutional volume, attributing uniform good results to the lack of financial competition in the Canadian system. This may indeed be true; however, a clear trend across the hospital volume quartiles (for which the highest is lower than the threshold of 50 RCs suggested by Barbieri et al) was seen that did not reach statistical significance (Table 1B). Against this background, it is unfortunate that the current report has categorised institutions into high- and lowvolume using five RCs per annum; it would be instructive to compare the data between the highest and lowest quartiles or quintiles. It should be borne in mind that institutions with the highest volumes have reported the lowest operative mortalities of approximately 2%, which should be considered the gold standard [9]. Given the overwhelming evidence (albeit predominantly from North America) for a volume-outcome relationship (VOR) for RC, along with an intuitive rationale, it might reasonably be asked why wholesale change has not been led by the profession to limit such work to fewer high-volume centres universally? Commercial and political pressures with perceived loss of revenue or institutional status are very real in any health care economy, and are particularly keenly felt in situations in which institutions compete for health care budget. Personal and professional interests may also dominate, with surgeons keen to maintain transferable skills involved in complex cancer surgery to continue to
DOI of original article: http://dx.doi.org/10.1016/j.eururo.2014.12.002. * Department of Oncology, Faculty of Medicine and Dentistry, Royal Hallamshire Hospital, University of Sheffield, Sheffield S10 2JF, UK. Tel. +44 114 2261229; Fax: +44 114 2712289. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.eururo.2015.01.010 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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EUROPEAN UROLOGY 67 (2015) 1063–1065
Table 1A – Mortality rate for cystectomy according to quintiles of institutional volume based on Medicare data for the number of cystectomies carried out in the USA annually between 1994 and 1999 (from Birkmeyer et al [6]) Number of cystectomies Observed mortality rate (%) a Adjusted odds ratio (95% CI)
11 2.9 0.46 (0.37–0.58)
CI = confidence interval. Death before discharge or within 30 d of surgery.
a
Table 1B – Trends in operative mortality between the lowest and highest quartiles for mean annual hospital volume and surgeon volume for cystectomy between 1992 and 2004 based on the Canadian Institute for Health Information discharge database for Ontario (from Kulkarni et al [8]) Lowest quartile Mean number of RCs per annum Operative mortality rate (%) a Adjusted odds ratio (95% CI) p value
0.77–3.22 4.3
inspection of the data presented by Hounsome et al, separated by age group and applying lines of best fit, suggests that different dynamics exist between low-volume and high-volume centres. Figure 1 demonstrates trends in 90-d mortality for the low- and higher-volume centres. For the higher-volume centres there appears to be convergence of the trends for the overall population and patients aged 80 yr, with no such trend evident for the low-volume centres; indeed, the mathematical prediction would be increasing mortality in the elderly were such centres to continue to offer such treatment. Where do we go from here? If we accept that highvolume surgeons and institutions get better results (as we must, given the evidence), then we must surely move rapidly to such a position, with the profession leading rather than lagging behind reluctantly. For example, in England we could suggest around 30 such institutions, each carrying out more than 50 procedures; every other urological community will need to make its own calculations. Mandatory prospective auditing of processes and results for centres providing such a service, focussing on the high-risk groups, and publication of individual surgeon outcomes are required to underpin ongoing improvement. In addition, the overall management of all patients with high-grade disease in this age group should be documented; such a denominator against which to set any changes in mortality is essential. Geography is likely to be a challenge in some areas, but reluctance to travel may be overcome by education and investment. Such changes have profound implications, not least the challenge of maintaining a comprehensive urological service around such high-volume pelvic cancer centres, and will require strong leadership and
Highest quartile 19.43–32.63 2.9 0.975 (0.947–1.003) 0.074
RC = radical cystectomy; CI = confidence interval. Death before discharge or within 30 d of surgery.
a
provide wider local urological services, including an emergency service for trauma, for instance. The current study does add more information about the outcomes of RC in an elderly cohort. Age in this setting is an imperfect surrogate marker for comorbidity and functional reserve to cope with any adverse surgical event, just as surgeon and institutional volumes are imperfect surrogate markers of quality of care, but they are the best we currently have. The rising rate of RC in older age groups is probably being driven by a combination of increases in patient knowledge and expectations, coupled with the documented efficacy of RC in this population [10], increasing the acceptability of offering radical surgery, despite the known risks. It is perhaps by concentrating on this high-risk group that we can identify meaningful VOR trends. Closer
[(Fig._1)TD$IG]
40.0
(A)
Annual mortality ≥80 yr Trens in overall mortality Trend in mortality ≥80 yr
30.0 25.0 20.0 15.0
30 25 20 15
10.0
10
5.0
5
0.0 1998
1999 2000 2001
2002 2003 2004 2005 2006
(B)
35
Annual mortality (%)
Annual mortality (%)
35.0
40
Overall annual mortality
2007 2008 2009 2010
0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
2009 2010
Fig. 1 – Percentage 90-d mortality overall and in patients aged I80 yr, along with trend lines, for (A) higher-volume centres (five or more radical cystectomies per annum) and (B) lower-volume centres (fewer than five radical cystectomies per annum) between 1998 and 2010.
EUROPEAN UROLOGY 67 (2015) 1063–1065
vision in national workforce planning. In training, identification of the factors that define surgeons with the best results should be sought through qualitative research. Finally, a closely mentored relationship for newly qualified urologists, specifically for such high-risk surgery outside the standard training programme, should be instituted for those who show the most aptitude during urological training, perhaps in simulation, to develop the future highvolume surgeons; our patients deserve no less.
1065
[4] McCabe JE, Jibawi A, Javle PM. Radical cystectomy: defining the threshold for a surgeon to achieve optimum outcomes. Postgrad Med J 2007;83:556–60. [5] Fairey AS, Jacobsen NB, Chetner MP, et al. Associations between comorbidity, and overall survival and bladder cancer specific survival after radical cystectomy: results from the Alberta Urology Institute radical cystectomy database. J Urol 2009;182:85–93. [6] Birkmeyer JD, Siewers AE, Finlayson EVA, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002;346: 1128–37. [7] Barbieri CE, Lee B, Cookson MS, et al. Association of procedure
Conflicts of interest: The author has nothing to disclose.
volume with radical cystectomy outcomes in a nationwide database. J Urol 2007;178:1418–22. [8] Kulkarni GS, Urbach DR, Austin PC, Fleshner NE, Laupacis A. Impact
References
of provider volume on operative mortality after radical cystectomy in a publicly funded healthcare system. Can Urol Assoc J 2013;7:
[1] Hounsome LS, Verne J, McGrath JS, Gillatt DA. Trends in operative caseload and mortality rates after radical cystectomy for bladder cancer in England for 1998-2010. Eur Urol 2015;67:1056–62. [2] Kassouf W. Uptake of neoadjuvant chemotherapy for invasive bladder cancer. Can Urol Assoc J 2014;8:e294–5. [3] Rosario DJ, Becker M, Anderson JB. The changing pattern of mortality and morbidity from radical cystectomy. BJU Int 2000;85:427–30.
425–9. [9] Quek ML, Stein JP, Daneshmand S, et al. A critical analysis of perioperative mortality from radical cystectomy. J Urol 2006;175: 886–9. [10] Donat SM, Siegrist T, Cronin A, Savage C, Milowsky MI, Herr HW. Radical cystectomy in octogenarians—does morbidity outweigh the potential survival benefits? J Urol 2010;183:2171–7.
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 1056–1062 of this issue
Mortality Following Radical Cystectomy: A Good Start, but How Low Can We Go? Derek J. Rosario * Department of Oncology, Faculty of Medicine and Dentistry, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK
In this issue of European Urology, Hounsome and colleagues [1] describe improving outcomes following radical cystectomy (RC) in England between 1998 and 2010, suggesting neoadjuvant chemotherapy (NAC), centralisation, enhanced recovery protocols (enhanced recovery after surgery, ERAS), and fellowship training as contributors. The authors are to be congratulated on such a thorough analysis; however, as with any retrospective output of an administrative database, confounding variables cannot be allowed for, so uncertainties remain as to the conclusions. This has been acknowledged in the manuscript, but the overall contribution to the literature warrants further comment. Given an absolute reduction in 90-d mortality of 5%, improvement in surgical care seems to be mostly responsible rather than NAC, particularly in the general setting of low NAC uptake [2]. Similarly, reports of reduced perioperative mortality preceded centralisation [3], which casts some doubt as to the efficacy of the centralisation enforced by the National Institute of Clinical Excellence Improving Outcomes Guidance. There is little evidence supporting the notion that ERAS protocols reduce perioperative mortality. Training is indeed essential, and I return to this later. Assuming a basic level of care provision, three features determine perioperative mortality: (1) patient selection, (2) operative competence (including anaesthetic administration), and (3) the effectiveness of retrieval strategies when adverse events occur; each of these is influenced in turn by the surgeon’s expertise, the institutional caseload, and the overall health care resource. Both surgeon and institutional case-volumes matter, but optimal levels are contentious. Minimum surgeon volumes of eight [4] and 10 RCs per annum [5] have been suggested,
the former against high overall inpatient mortality of 5.6%. The evidence that institutional volume affects outcome is strong but variable; Birkmeyer et al [6] observed reduced mortality at a level of >11 RCs (Table 1A), whereas Barbieri et al [7] suggested that 50 RCs per annum were associated with the best outcomes. Kulkarni et al [8] found no significant impact of institutional volume, attributing uniform good results to the lack of financial competition in the Canadian system. This may indeed be true; however, a clear trend across the hospital volume quartiles (for which the highest is lower than the threshold of 50 RCs suggested by Barbieri et al) was seen that did not reach statistical significance (Table 1B). Against this background, it is unfortunate that the current report has categorised institutions into high- and lowvolume using five RCs per annum; it would be instructive to compare the data between the highest and lowest quartiles or quintiles. It should be borne in mind that institutions with the highest volumes have reported the lowest operative mortalities of approximately 2%, which should be considered the gold standard [9]. Given the overwhelming evidence (albeit predominantly from North America) for a volume-outcome relationship (VOR) for RC, along with an intuitive rationale, it might reasonably be asked why wholesale change has not been led by the profession to limit such work to fewer high-volume centres universally? Commercial and political pressures with perceived loss of revenue or institutional status are very real in any health care economy, and are particularly keenly felt in situations in which institutions compete for health care budget. Personal and professional interests may also dominate, with surgeons keen to maintain transferable skills involved in complex cancer surgery to continue to
DOI of original article: http://dx.doi.org/10.1016/j.eururo.2014.12.002. * Department of Oncology, Faculty of Medicine and Dentistry, Royal Hallamshire Hospital, University of Sheffield, Sheffield S10 2JF, UK. Tel. +44 114 2261229; Fax: +44 114 2712289. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.eururo.2015.01.010 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
1064
EUROPEAN UROLOGY 67 (2015) 1063–1065
Table 1A – Mortality rate for cystectomy according to quintiles of institutional volume based on Medicare data for the number of cystectomies carried out in the USA annually between 1994 and 1999 (from Birkmeyer et al [6]) Number of cystectomies Observed mortality rate (%) a Adjusted odds ratio (95% CI)
11 2.9 0.46 (0.37–0.58)
CI = confidence interval. Death before discharge or within 30 d of surgery.
a
Table 1B – Trends in operative mortality between the lowest and highest quartiles for mean annual hospital volume and surgeon volume for cystectomy between 1992 and 2004 based on the Canadian Institute for Health Information discharge database for Ontario (from Kulkarni et al [8]) Lowest quartile Mean number of RCs per annum Operative mortality rate (%) a Adjusted odds ratio (95% CI) p value
0.77–3.22 4.3
inspection of the data presented by Hounsome et al, separated by age group and applying lines of best fit, suggests that different dynamics exist between low-volume and high-volume centres. Figure 1 demonstrates trends in 90-d mortality for the low- and higher-volume centres. For the higher-volume centres there appears to be convergence of the trends for the overall population and patients aged 80 yr, with no such trend evident for the low-volume centres; indeed, the mathematical prediction would be increasing mortality in the elderly were such centres to continue to offer such treatment. Where do we go from here? If we accept that highvolume surgeons and institutions get better results (as we must, given the evidence), then we must surely move rapidly to such a position, with the profession leading rather than lagging behind reluctantly. For example, in England we could suggest around 30 such institutions, each carrying out more than 50 procedures; every other urological community will need to make its own calculations. Mandatory prospective auditing of processes and results for centres providing such a service, focussing on the high-risk groups, and publication of individual surgeon outcomes are required to underpin ongoing improvement. In addition, the overall management of all patients with high-grade disease in this age group should be documented; such a denominator against which to set any changes in mortality is essential. Geography is likely to be a challenge in some areas, but reluctance to travel may be overcome by education and investment. Such changes have profound implications, not least the challenge of maintaining a comprehensive urological service around such high-volume pelvic cancer centres, and will require strong leadership and
Highest quartile 19.43–32.63 2.9 0.975 (0.947–1.003) 0.074
RC = radical cystectomy; CI = confidence interval. Death before discharge or within 30 d of surgery.
a
provide wider local urological services, including an emergency service for trauma, for instance. The current study does add more information about the outcomes of RC in an elderly cohort. Age in this setting is an imperfect surrogate marker for comorbidity and functional reserve to cope with any adverse surgical event, just as surgeon and institutional volumes are imperfect surrogate markers of quality of care, but they are the best we currently have. The rising rate of RC in older age groups is probably being driven by a combination of increases in patient knowledge and expectations, coupled with the documented efficacy of RC in this population [10], increasing the acceptability of offering radical surgery, despite the known risks. It is perhaps by concentrating on this high-risk group that we can identify meaningful VOR trends. Closer
[(Fig._1)TD$IG]
40.0
(A)
Annual mortality ≥80 yr Trens in overall mortality Trend in mortality ≥80 yr
30.0 25.0 20.0 15.0
30 25 20 15
10.0
10
5.0
5
0.0 1998
1999 2000 2001
2002 2003 2004 2005 2006
(B)
35
Annual mortality (%)
Annual mortality (%)
35.0
40
Overall annual mortality
2007 2008 2009 2010
0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
2009 2010
Fig. 1 – Percentage 90-d mortality overall and in patients aged I80 yr, along with trend lines, for (A) higher-volume centres (five or more radical cystectomies per annum) and (B) lower-volume centres (fewer than five radical cystectomies per annum) between 1998 and 2010.
EUROPEAN UROLOGY 67 (2015) 1063–1065
vision in national workforce planning. In training, identification of the factors that define surgeons with the best results should be sought through qualitative research. Finally, a closely mentored relationship for newly qualified urologists, specifically for such high-risk surgery outside the standard training programme, should be instituted for those who show the most aptitude during urological training, perhaps in simulation, to develop the future highvolume surgeons; our patients deserve no less.
1065
[4] McCabe JE, Jibawi A, Javle PM. Radical cystectomy: defining the threshold for a surgeon to achieve optimum outcomes. Postgrad Med J 2007;83:556–60. [5] Fairey AS, Jacobsen NB, Chetner MP, et al. Associations between comorbidity, and overall survival and bladder cancer specific survival after radical cystectomy: results from the Alberta Urology Institute radical cystectomy database. J Urol 2009;182:85–93. [6] Birkmeyer JD, Siewers AE, Finlayson EVA, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002;346: 1128–37. [7] Barbieri CE, Lee B, Cookson MS, et al. Association of procedure
Conflicts of interest: The author has nothing to disclose.
volume with radical cystectomy outcomes in a nationwide database. J Urol 2007;178:1418–22. [8] Kulkarni GS, Urbach DR, Austin PC, Fleshner NE, Laupacis A. Impact
References
of provider volume on operative mortality after radical cystectomy in a publicly funded healthcare system. Can Urol Assoc J 2013;7:
[1] Hounsome LS, Verne J, McGrath JS, Gillatt DA. Trends in operative caseload and mortality rates after radical cystectomy for bladder cancer in England for 1998-2010. Eur Urol 2015;67:1056–62. [2] Kassouf W. Uptake of neoadjuvant chemotherapy for invasive bladder cancer. Can Urol Assoc J 2014;8:e294–5. [3] Rosario DJ, Becker M, Anderson JB. The changing pattern of mortality and morbidity from radical cystectomy. BJU Int 2000;85:427–30.
425–9. [9] Quek ML, Stein JP, Daneshmand S, et al. A critical analysis of perioperative mortality from radical cystectomy. J Urol 2006;175: 886–9. [10] Donat SM, Siegrist T, Cronin A, Savage C, Milowsky MI, Herr HW. Radical cystectomy in octogenarians—does morbidity outweigh the potential survival benefits? J Urol 2010;183:2171–7.
