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

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.

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.

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

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 PDCartwright RBriel MTikkinen KAGuyatt GH Guidelines of guidelines: thromboprophylaxis for urological surgery. BJU Int 2016118351– 8
  2. Naik RMandal IHampson A et al. The role of extended venous thromboembolism prophylaxis for major urological cancer operations. BJU Int 2019; 124: 935-44
  3. Tikkinen KACraigie SAgarwal A et al. Procedure‐specific risks of thrombosis and bleeding in urological cancer surgery: systematic reviews and meta‐analyses. Eur Urol 201873242– 51
  4. Tikkinen KACartwright RGould 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 SRasmussen MSKing R et al. Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery. Cochrane Database Syst Rev 20193CD004318
  7. Tikkinen KAAgarwal ACraigie S et al. Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology. Syst Rev 201423150. DOI: 10.1186/2046‐4053‐3‐150.

 

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

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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Article of the month: Prostate cancer mortality rates in Peru and its geographical regions

Every month, the Editor-in-Chief selects an Article of the Month 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 urological community. These are intended to provoke comment and discussion and 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.

Prostate cancer mortality rates in Peru and its geographical regions

Junior Smith Torres-Roman*, Eloy F. Ruiz, Jose Fabian Martinez-Herrera§, Sonia Faria Mendes Braga, Luis Taxa**, Jorge Saldaña-Gallo*, Mariela R. Pow-Sang††, Julio M. Pow-Sang‡‡ and Carlo La Vecchia§§

 

*Clinica de Urologia Avanzada UROZEN, Lima, Facultad de Medicina Humana, Universidad Nacional San Luis Gonzaga, Ica, CONEVID, Unidad de Conocimiento y Evidencia, Universidad Peruana Cayetano Heredia, Lima, Peru, §Cancer Center, Medical Center American British Cowdray, Mexico City, Mexico, Department of Social and Preventive Medicine, Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, **Instituto Nacional de Enfermedades Neoplásicas, ††Department of Urology, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru, ‡‡Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA, and §§Department of Clinical Sciences and Community Health, Universitá degli Studi di Milano, Milan, Italy

 

Read the full article

Abstract

Objective

To evaluate the mortality rates for prostate cancer according to geographical areas in Peru between 2005 and 2014.

Materials and Methods

Information was extracted from the Deceased Registry of the Peruvian Ministry of Health. We analysed age‐standardised mortality rates (world population) per 100 000 men. Spatial autocorrelation was determined according to the Moran Index. In addition, we used Cluster Map to explore relations between regions.

Fig. 1. Peru geographical zones by provinces. The asterisk denotes the province of Callao. Source: National Statistics Institute

Results

Mortality rates increased from 20.9 (2005–2009) to 24.1 (2010–2014) per 100 000 men, an increase of 15.2%. According to regions, during the period 2010–2014, the coast had the highest mortality rate (28.9 per 100 000), whilst the rainforest had the lowest (7.43 per 100 000). In addition, there was an increase in mortality in the coast and a decline in the rainforest over the period 2005–2014. The provinces with the highest mortality were Piura, Lambayeque, La Libertad, Callao, Lima, Ica, and Arequipa. Moreover, these provinces (except Arequipa) showed increasing trends during the years under study. The provinces with the lowest observed prostate cancer mortality rates were Loreto, Ucayali, and Madre de Dios. This study showed positive spatial autocorrelation (Moran’s I: 0.30, P= 0.01).

Conclusion

Mortality rates from prostate cancer in Peru continue to increase. These rates are higher in the coastal region compared to those in the highlands or rainforest.

Read more Articles of the week

 

Editorial: The burden of urological cancers in low‐ and middle‐income countries

The burden of cancer in low‐ and middle‐income countries (LMICs) continues to rise [1]. Evaluation of geographical differences in cancer mortality statistics is specifically of interest in LMICs as (inter)national guidelines are potentially less embedded in standard care, and objective measurements to assess underlying mechanisms/explanations for the burden of cancer are often lacking. Monitoring mortality statistics in these countries can thus help assess the effectiveness of national and regional health systems in treating and caring for patients with cancer [1].

Torres‐Roman et al. [2] deserve to be congratulated for their efforts to monitor mortality rates for prostate cancer at both a regional and national level in Peru. The CONCORD initiative from the WHO previously reported prostate cancer statistics for Peru, but data were limited to the capital area of Lima [1]. Torres‐Raman et al. [2] report prostate cancer mortality rates between 2005 and 2014 based on data from the Peruvian Ministry of Health, which covers ~70% of all healthcare providers in Peru. Apart from an overall increase of 15% in mortality rates, substantial variation was observed by geographical region. Mortality rates increased by 16% in the coastal region and highlands, whereas in the rainforest region the rates decreased by 19% [2]. One potential explanation for these observed differences could be the difference in ethnic and racial characteristics. The coastal region in Peru has a strong African influence and also has a larger proportion of men aged >65 years. In addition to potential differences in access to healthcare, some of the variation in prostate cancer mortality statistics most likely reflects a deficiency in reporting systems. Even though this study has its limitations due to missing data and lack of information on other important variables, such as ethnicity and socioeconomic status, it provides a first base for a critical assessment of prostate cancer care in Peru.

Studies like this one from Torres‐Roman et al. [2] show that there is a need for improvement and standardisation of (prostate) cancer care in LMICs, but also a need for improvement in data capturing, so that objective measurements can be put in place. The years of healthy life lost due to prostate cancer, as well as other urological cancers, in LMICs is increasing substantially. Even though each tumour group has its own specifications in terms of prevention and control, an epidemiological assessment of cancer burden based on the experience for urological cancers (i.e., prostate, bladder, kidney and testicular) can therefore inform future assessments of cancer burden. The urological tumour group covers both common and less common cancers (e.g. prostate vs kidney cancer), sex‐specific and cancers that affect both sexes (e.g. testicular vs bladder cancer), cancers with less known risk factors and those strongly linked with lifestyle risk factors (e.g. prostate vs bladder cancer).

It is encouraging to see an increase in the number of studies evaluating the burden of cancer in LMICs [3]; however, given the consistency in observations of an increase in mortality, there is an urgent need to further invest in prevention and management, as well as the infrastructure to collect all relevant data at a national level in these LMICs. Accurate information about cancer burden and how this varies between regions is essential to plan for an adequate health‐system response.

References

  1. Allemani, CMatsuda, TCarlo, V et al. Global surveillance of trends in cancer survival 2000‐14 (CONCORD‐3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population‐based registries in 71 countries. Lancet 20183911023– 75
  2. Torres‐Roman, JRuiz, EMartinez‐Herrera, J et al. Prostate cancer mortality rates in Peru and its geographic regions. BJU Int 2019123595– 601
  3. Carioli, GVecchia, CBertuccio, P et al. Cancer mortality predictions for 2017 in Latin America. Ann Oncol 2017282286– 97

 

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