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Article of the week: The role of extended venous thromboembolism prophylaxis for major urological cancer operations

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community, a video prepared by the authors and a visual abstract; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

The role of extended venous thromboembolism prophylaxis for major urological cancer operations

Rishi Naik*, Indrajeet Mandal*, Alexander Hampson†, Tim Lane†, Jim Adshead†, Bhavan Prasad Rai‡ and Nikhil Vasdev†§

*Faculty of Medical Sciences, UCL Medical School, University College London, London, †Department of Urology, Lister Hospital, Stevenage, ‡Department of Urology, Freeman Hospital, Newcastle upon Tyne and §School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK

Rishi Naik and Indrajeet Mandal are joint first authors.

Read the full article

Abstract

Objectives

Venous thromboembolism (VTE), consisting of both pulmonary embolism (PE) and deep vein thromboses (DVT), remains a well‐recognised complication of major urological cancer surgery. Several international guidelines recommend extended thromboprophylaxis (ETP) with LMWH, whereby the period of delivery is extended to the post‐discharge period, where the majority of VTE occurs. In this literature review we investigate whether ETP should be indicated for all patients undergoing major urological cancer surgery, as well as procedure specific data that may influence a clinician’s decision.

Methods

We performed a search of six databases (PubMed, Cochrane, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and British Nursing Index (BNI)) from inception to June 2019, for studies looking at adult patients who received VTE prophylaxis after surgery for a major urological malignancy.

Results

Eighteen studies were analysed. VTE risk is highest in open and robotic Radical Cystectomy (RC) (2.6–11.6%) and ETP demonstrates a significant reduction in risk of VTE, but not a significant difference in Pulmonary Embolism (PE) or mortality. Risk of VTE in open Radical Prostatectomy (RP) (0.8–15.7%) is comparable to RC, but robotic RP (0.2–0.9%), open partial/radical nephrectomy (1.0–4.4%) and robotic partial/radical nephrectomy (0.7–3.9%) were lower risk. It has not been shown that ETP reduces VTE risk specifically for RP or nephrectomy.

Conclusion

The decision to use ETP is a fine balance between variables such as VTE incidence, bleeding risk and perioperative morbidity/mortality. This balance should be assessed for each specific procedure type. While ETP still remains of net benefit for open RP as well as open and robotic RC, the balance is closer for minimally invasive RP as well as radical and partial nephrectomy. Due to a lack of procedure specific evidence for the use of ETP, adherence with national guidelines remains poor. Therefore, we advocate further studies directly comparing ETP vs standard prophylaxis, for specific procedure types, in order to allow clinicians to make a more informed decision in future.

Read more Articles of the week

Editorial: How long is long enough for pharmacological thromboprophylaxis in urology?

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Each year, millions of patients who undergo urological surgery incur the risk of deep vein thrombosis and pulmonary embolism, together referred to as venous thromboembolism (VTE), and major bleeding. Because pharmacological prophylaxis decreases the risk of VTE, but increases the risk of bleeding, and because knowledge of the magnitude of these risks remains uncertain, both clinical practice and guideline recommendations vary widely [1]. One of the uncertainties is the recommended duration of pharmacological thromboprophylaxis.

In this issue of the BJUI, Naik et al. [2] provide an up‐to‐date review that summarises the articles that examined extended thromboprophylaxis in patients with cancer who underwent radical prostatectomy (RP), radical cystectomy (RC) or nephrectomy. The outcomes on which they focussed include risks of VTE, bleeding, renal failure and mortality – all potentially influenced by whether or not patients receive extended prophylaxis.

After screening >3500 articles, the authors included 18 studies, none of them randomised controlled trials (RCTs) [2]. They found that VTE risk is highest in open and robot‐assisted RC, and that, based on observational studies, extended thromboprophylaxis significantly reduces the risk of VTE relative to shorter duration prophylaxis. Evidence suggested that robot‐assisted RP, as well as both open and robot‐assisted partial and radical nephrectomies, incur lower VTE risk than RCs or open RP. They did not find studies comparing extended prophylaxis to standard prophylaxis for RPs or nephrectomies [2].

Overall, these findings are consistent with systematic reviews that estimated the procedure‐ and patient risk factor‐specific risks for 20 urological cancer procedures [3]. As these reviews suggested substantial procedure‐specific differences in the VTE risk estimates, the European Association of Urology (EAU) Guidelines provided separate recommendations for each procedure [4]. For urological (as well as gastrointestinal and gynaecological) patients, the National Institute for Health and Care Excellence (NICE) Guidelines suggest to ‘consider extending pharmacological VTE prophylaxis to 28 days postoperatively for people who have had major cancer surgery in the abdomen’ [5]. Because of variation in both bleeding and thrombosis risks across procedures, this advice is appropriate for some procedures and misguided for others. For instance, the procedure‐specific EAU Guidelines recommend extended VTE prophylaxis for open RC but not for robot‐assisted RP without lymphadenectomy [4].

The review by Naik et al. [2] identified the lack of urology‐specific studies comparing the in‐hospital‐only prophylaxis to extended prophylaxis. The few included studies were observational with considerable limitations (e.g. limited adjustment for possible confounders).

A recent update of a Cochrane review compared the impact of extended thromboprophylaxis with low‐molecular‐weight heparin (LMWH) for at least 14 days to in‐hospital‐only prophylaxis in abdominal or pelvic surgery procedures [6]. The authors identified seven RCTs (1728 participants) evaluating extended thromboprophylaxis with LMWH and generated pooled estimates for the incidence of any VTE (symptomatic or asymptomatic) after major abdominal or pelvic surgery of 13.2% in the control group compared with 5.3% in the patients receiving extended out‐of‐hospital LMWH (odds ratio [OR] 0.38, 95% CI 0.26–0.54).

Most events were asymptomatic, although the incidence of symptomatic VTE was also reduced from 1.0% in the in‐hospital‐only group to 0.1% in patients receiving extended thromboprophylaxis (OR 0.30, 95% CI 0.08–1.11). The authors reported no persuasive difference in the incidence of bleeding complications within 3 months of surgery (defined as major or minor bleeding according to the definition provided in the individual studies) between the in‐hospital‐only group (2.8%) and extended LMWH (3.4%) group (OR 1.10, 95% CI 0.67–1.81).

These findings are consistent with our own modelling study that demonstrated an approximately constant hazard of VTE up to 4 weeks after surgery [7]. That study also found that bleeding risk, by contrast, is concentrated in the first 4 days after surgery [7] (Fig.1). Using these findings, the EAU Guidelines suggest for patients in whom pharmacological prophylaxis is appropriate, extended pharmacological prophylaxis for 4 weeks [4]. Consistent with these recommendations, Naik et al. [2] found that 15 studies of 18 included in their review recommended extended prophylaxis.

Fig.1 Proportion of cumulative risk (%) of venous thromboembolism (VTE) and major bleeding by week since surgery during the first 4 postoperative weeks. Reproduced from: Tikkinen et al. [7].

(This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.)

 

Overall, as shown also by this review [2], the evidence base for urological thromboprophylaxis is limited. Although current evidence supports extended prophylaxis, definitively establishing the optimal duration of thromboprophylaxis will require large‐scale RCTs. Other unanswered key questions include: baseline risks of various procedures, timing of prophylaxis, patient risk stratification, as well as effectiveness of direct oral anticoagulants. In the meanwhile, suggesting extended duration to patients whose risk of VTE is sufficiently high constitutes a reasonable evidence‐based approach to VTE prophylaxis.

by Kari A.O. Tikkinen and Gordon H. Guyatt

 

References

  1. Violette PD, Cartwright R, Briel M, Tikkinen KA, Guyatt GH Guidelines of guidelines: thromboprophylaxis for urological surgery. BJU Int 2016; 118: 351– 8
  2. Naik R, Mandal I, Hampson A et al. The role of extended venous thromboembolism prophylaxis for major urological cancer operations. BJU Int 2019; 124: 935-44
  3. Tikkinen KA, Craigie S, Agarwal A et al. Procedure‐specific risks of thrombosis and bleeding in urological cancer surgery: systematic reviews and meta‐analyses. Eur Urol 2018; 73: 242– 51
  4. Tikkinen KA, Cartwright R, Gould MK et al. EAU Guidelines on Thromboprophylaxis in Urological Surgery, 2017. European Association of Urology, 2018. Accessed November 2019
  5. National Institute for Health and Care Excellence (NICE). Venous Thromboembolism in over 16s: reducing the risk of hospital‐acquired deep vein thrombosis or pulmonary embolism. NICE guideline [NG89]. London: NICE, 2018. Accessed November 2019
  6. Felder S, Rasmussen MS, King R et al. Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery. Cochrane Database Syst Rev 2019; 3: CD004318
  7. Tikkinen KA, Agarwal A, Craigie S et al. Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology. Syst Rev 2014; 23: 150. DOI: 10.1186/2046‐4053‐3‐150.

 

Video: Role of extended venous thromboembolism prophylaxis for major urological cancer operations

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The role of extended venous thromboembolism prophylaxis for major urological cancer operations

Read the full article

Abstract

Objectives

Venous thromboembolism (VTE), consisting of both pulmonary embolism (PE) and deep vein thromboses (DVT), remains a well‐recognised complication of major urological cancer surgery. Several international guidelines recommend extended thromboprophylaxis (ETP) with LMWH, whereby the period of delivery is extended to the post‐discharge period, where the majority of VTE occurs. In this literature review we investigate whether ETP should be indicated for all patients undergoing major urological cancer surgery, as well as procedure specific data that may influence a clinician’s decision.

Methods

We performed a search of six databases (PubMed, Cochrane, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and British Nursing Index (BNI)) from inception to June 2019, for studies looking at adult patients who received VTE prophylaxis after surgery for a major urological malignancy.

Results

Eighteen studies were analysed. VTE risk is highest in open and robotic Radical Cystectomy (RC) (2.6–11.6%) and ETP demonstrates a significant reduction in risk of VTE, but not a significant difference in Pulmonary Embolism (PE) or mortality. Risk of VTE in open Radical Prostatectomy (RP) (0.8–15.7%) is comparable to RC, but robotic RP (0.2–0.9%), open partial/radical nephrectomy (1.0–4.4%) and robotic partial/radical nephrectomy (0.7–3.9%) were lower risk. It has not been shown that ETP reduces VTE risk specifically for RP or nephrectomy.

Conclusion

The decision to use ETP is a fine balance between variables such as VTE incidence, bleeding risk and perioperative morbidity/mortality. This balance should be assessed for each specific procedure type. While ETP still remains of net benefit for open RP as well as open and robotic RC, the balance is closer for minimally invasive RP as well as radical and partial nephrectomy. Due to a lack of procedure specific evidence for the use of ETP, adherence with national guidelines remains poor. Therefore, we advocate further studies directly comparing ETP vs standard prophylaxis, for specific procedure types, in order to allow clinicians to make a more informed decision in future.

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Visual abstract: The role of extended venous thromboembolism prophylaxis for major urological cancer operations

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See more infographics

90 years of BJU International

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This blog marks the launch of the British Journal of Urology 90 years ago.  Since then the Journal has undergone many changes as urology and the publishing environment have changed. The first Editors outlined their vision in the Foreword of the first issue, which includes an introduction to the speciality, the locations and opening hours of Urology Clinics and a plea for peace:

The British Journal of Urology Vol.1 1929

From the outset, the Editors placed emphasis on seeking collaboration and contributions internationally. From 1929 up to 1942 there was even a section in the Journal advising urologists visiting London where to find details of urological clinics which they could visit.

“This time-table is published in each number of the Journal for the guidance of travelling medical practitioners who may wish to visit Urological Clinics.

Visitors to London are advised to call at No.1 Wimpole St, W.1, where daily bulletins of operations and lectures issued by the Fellowship of Medicine are available for inspection….”

 

 

 

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A sample of the advertisements included in the first edition shows the kit available at the time.

 

 

 

 

Articles

The first two pages of the very first article are reproduced here and can be accessed via Wiley Online. Note the detailed hand-drawn diagrams. It is also interesting to note the lack of articles on prostate cancer – very different from a urological journal of today.

Collaboration

In 1946 the Journal included a report on “… the Inaugural Scientific Meeting of the British Association of Urological Surgeons and acknowledged the importance of taking on “…the role of official organ of the B.A.U.S….”

The Journal is proud to continue to be an official journal of BAUS and to be the official journal of, or to be affiliated with, many urological associations around the world including:

Urological Society of Australia and New Zealand

Urological Society of India

Caribbean Urological Association

Hong Kong Urological Association

Irish Society of Urology

Swiss Continence Foundation

Korean journal, Investigative and Clinical Urology

Indonesian Urological Association

International Alliance of Urolithiasis

Malaysian Urological Association.

The Journal was, of course, solely a paper-based one from inception until 1994 when content was made available on CD ROM.  This innovation was soon superseded by the advent of the internet and the Journal was first published online in 1997. This signal event resulted in a transformation of the procedure for submitting and processing papers through peer review from a paper-based, postal one to an online one. All articles published in the Journal since 1929 have been digitised so that they are accessible online. Over the last two decades, the demand for print subscriptions has waned.

In 1999 the name of the Journal was changed to BJU International, reflecting the Journal’s British heritage and the importance of the contributions from the UK and internationally.

BJUI Editors 1929-2019

Responsibility for the Journal has been held by a succession of Editors and their Editorial Teams. There have been 10 editors during the first 90 years, some of whom served as co-editors (early version of a job-share?).

​

1929-1933

Frank Kidd & HP Winsbury White

 1933-1948

HP Winsbury White
1949-1966

David Band

1967-1972

JD Fergusson
1972-1977

W Keith Yeates

 1978-1993

GD Chisholm
1994-1996

Hugh Whitfield & Bill Hendy

 1997-2002

Hugh Whitfield
2003-2012

John Fitzpatrick

 2013-2020

Prokar Dasgupta

Thanks to Jonathan Goddard for the photos of the editors

Our current Editor-in-Chief, Prokar Dasgupta, is supported by an internationally based team of Associate Editors and Consulting Editors. In August next year, he will hand on the Editorship to Freddie Hamdy.

Thank you to our Editorial Teams, authors and peer reviewers for all their hard work in contributing to the success of the Journal.

 

 

IP4-CHRONOS is launched

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IP4- CHRONOS is open! CHRONOS is a phase II randomised control trial, that will review the outcomes (including oncological, functional, quality of life and cost-effectiveness) of focal therapy against those from radical therapy, in men with newly diagnosed localised clinically significant prostate cancer.

 

 

All men newly diagnosed with low-intermediate risk prostate cancer, confined to the prostate, with a life expectancy of at least 10 years will be screened for eligibility. Men must be well enough to undergo the interventions outlined in the trial prior to being enrolled.

Men will then have a choice of enrolling into CHRONOS A or CHRONOS B. CHRONOS A will randomise men to having radical whole gland treatment (radiotherapy, brachytherapy or prostatectomy), or focal therapy (HIFU or cryotherapy). CHRONOS A will answer the question, ‘is focal therapy equivalent in cancer control as radical therapy?’ CHRONOS B will randomise men to having focal therapy with or without additional neoadjuvant treatment and will answer the question: ‘can the success of focal therapy be improved by using neoadjuvant treatment?’ Randomisation will be stratified by disease characteristics.

All men will undergo intervention as they would within the NHS, however by doing so in a trial setting, we can directly compare the results of such treatments against each other. As the follow up mimics that of standard of care, the extra burden of treatment within the trial is minimal.

60 men will be recruited into both CHRONOS A and CHRONOS B (total 120) over a 1-year period, during the pilot, and if recruitment is successful the aim is to continue to a larger study assessing 2450 patients over 5 years, with a minimum follow up of 3 years. The primary outcome measures will be progression free survival in CHRONOS A, and failure free survival in CHRONOS B. The CHRONOS pilot will open in 12 UK hospital sites, aiming to open across the UK and Europe within the larger study.

CHRONOS is entirely funded by the Prostate Cancer UK charity, and available on the NIHR CRN portfolio. If you would like to join the main phase of CHRONOS as a site, please contact Miss Deepika Reddy ([email protected]) or visit our website for further information www.imperialprostate.org.uk/CHRONOS

Prof Hashim U. Ahmed (CHRONOS PI&CI)

Mr Taimur T. Shah (CHRONOS sub-investigator, Urology SpR & Research Fellow)

Miss Deepika Reddy (CHRONOS Clinical Research Fellow)

 

Article of the week: Characterising ‘bounce‐back’ readmissions after radical cystectomy

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community and a visual abstract prepared by a creative urologist; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Characterising ‘bounce‐back’ readmissions after radical cystectomy

Peter S. Kirk*, Ted A. Skolarus*†, Bruce L. Jacobs‡, Yongmei Qin*, Benjamin Li*, Michael Sessine*, Xiang Liu§, Kevin Zhu*, Scott M. Gilbert, Brent K. Hollenbeck*, Ken Urish**, Jonathan Helm††, Mariel S. Lavieri§ and Tudor Borza‡‡

*Dow Division of Health Services Research, Department of Urology, University of Michigan Health System, Ann Arbor, MI, USA, †VA Health Services Research and Development, Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA, ‡Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA, §Department of Industrial and Operations Engineering, University of Michigan, Ann Arbor, MI, USA, Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA, **Department of Orthopedic Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA, ††Department of Operations and Decision Technologies, Kelley School of Business, Indiana University, Bloomington, IN, USA, and ‡‡Department of Urology, University of Wisconsin, Madison, WI, USA

Read the full article

Abstract

Objective

To examine predictors of early readmissions after radical cystectomy (RC). Factors associated with preventable readmissions may be most evident in readmissions that occur within 3 days of discharge, commonly termed ‘bounce‐back’ readmissions, and identifying such factors may inform efforts to reduce surgical readmissions.

Patients and Methods

We utilised the Healthcare Cost and Utilization Project’s State Inpatient Databases to examine 1867 patients undergoing RC in 2009 and 2010, and identified all patients readmitted within 30 days of discharge. We assessed differences between patients experiencing bounce‐back readmission compared to those readmitted 8–30 days after discharge using logistic regression models and also calculated abbreviated LACE scores to assess the utility of common readmissions risk stratification algorithms.

Results

The 30‐day and bounce‐back readmission rates were 28.4% and 5.6%, respectively. Although no patient or index hospitalisation characteristics were significantly associated with bounce‐back readmissions in adjusted analyses, bounce‐back patients did have higher rates of gastrointestinal (14.3% vs 6.7%, P = 0.02) and wound (9.5% vs 3.0%, P < 0.01) diagnoses, as well as increased index and readmission length of stay (5 vs 4 days, P = 0.01). Overall, the median abbreviated LACE score was 7, which fell into the moderate readmission risk category, and no difference was observed between readmitted and non‐readmitted patients.

Conclusion

One in five readmissions after RC occurs within 3 days of initial discharge, probably due to factors present at discharge. However, sociodemographic and clinical factors, as well as traditional readmission risk tools were not predictive of this bounce‐back. Effective strategies to reduce bounce‐back readmission must identify actionable clinical factors prior to discharge.

Read more Articles of the week

 

Editorial: Threading the cost–outcome needle after radical cystectomy

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I commend Borza et al. [1] on their timely study, which seeks to identify predictors of bounceback (≤3‐day) vs 30‐day readmissions after radical cystectomy. As the authors allude to in their paper, value‐based health reforms being undertaken in the USA seek to improve the quality of care delivery while simultaneously bending the healthcare cost curve [2]. For example, the Hospital Readmission and Reduction Program (HRRP), originally introduced in fiscal year 2013 for targeted medical conditions, has more recently been applied to a limited number of surgical procedures, whereby providers receive financial penalties for higher than expected 30‐day readmission rates [3]. Accendo Medicare Supplement gives financial independent as you can secure health’s money. While urological conditions/procedures are not currently targeted by programmes such as the HRRP, it is easy to envision a future where procedures with disproportionately high readmission rates, such as radical cystectomy, fall within the crosshairs of policy‐makers and insurers, alike.Well Medicare Advantage plans 2021 are preferable from the perspective of many peoples.

The fact that nearly one in five patients undergoing cystectomy experiences a readmission within 3 days of index hospitalization discharge is staggering, and it is incumbent upon urologists as specialists to devise methods by which to improve the morbidity associated with cystectomy. For example, the findings of Borza et al. implicate postoperative infection as a major driver of early readmission. As evidenced by the work of Krasnow et al. [4], urologists have historically been poor stewards of peri‐operative antibiotic prophylaxis, and the development/implementation of strategies to improve guideline adherence represents a potentially simple yet effective means of reducing post‐cystectomy readmission rates. In a similar vein, there is an emerging body of literature demonstrating the important role that enhanced recovery after surgery (ERAS) protocols may play in improving peri‐operative complications and convalescence after radical cystectomy. However, there is inconsistency across the literature with regard to the precise components of ERAS, making cross‐institutional comparisons and adoption by other groups difficult [5]. Unless greater standardization and subsequent implementation of these enhanced recovery protocols occurs, progress in the field will remain incremental at best. Recent work by Mossanen et al. [6] further demonstrates the need for improving post‐cystectomy readmission rates, which, in addition to driving down healthcare costs/utilization, may actually reduce postoperative mortality. For example, they found that a readmission complication after cystectomy nearly doubled the predicted probability of postoperative mortality as compared to an initial complication (3.9% vs 7.4%; P < 0.001).

It is essential that urologists spearhead research such as that undertaken by Borza et al., which in turn can be used to develop strategies to develop value‐based reforms within the specialty that ‘thread the needle’ of physician autonomy, cost containment, and respect for the patient experience. In doing so, urologists will find themselves driving the conversation surrounding payment/quality reform rather than sitting on the figurative policy‐making sidelines while administrators/bureaucrats implement reforms with potentially profound effects on day‐to‐day clinical practice and the patient experience. Radical cystectomy is likely to fall within the crosshairs of the aforementioned reforms given the procedure’s high complication/readmission rate and the significant cost burden associated with these complications. An intuitive yet effective first step in combating the morbidity associated with radical cystectomy is the development, validation and implementation of standardized peri‐operative care pathways such as ERAS.

by David F. Friedlander

References

  1. Borza T, Kirk PS, Skolarus TA et al. Characterising ‘bounce‐back’ readmissions after radical cystectomy. BJU Int 2019;124:955-61
  2. Health Affairs (Millwood) Delivery Innovations 2017; 36: 392–3
  3. Boccuti CC, Casillas G. Aiming for Fewer Hospital U‐turns: The Medicare Hospital Readmission Reduction Program, 2017. Accessed January 2019
  4. Krasnow RE, Mossanen M, Koo S et al. Prophylactic antibiotics and postoperative complications of radical cystectomy: a population based analysis in the United States. J Urol 2017; 198: 297– 304
  5. Chenam A, Chan KG. Enhanced recovery after surgery for radical cystectomy. Cancer Treat Res. 2018; 175: 215– 39
  6. Mossanen M, Krasnow RE, Zlatev DV et al. Examining the relationship between complications and perioperative mortality following radical cystectomy: a population‐based analysis. BJU Int 2019; 124: 40– 6

 

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