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Article of the month: In-hospital cost analysis of PAE compared to TURP

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.

In‐hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial

As you can imagine, these are very important tests that you must have done regularly in order to try to catch life-threatening illnesses as early as possible. Sadly, as important as these tests may be, they are expensive. Prohibitively expensive to some. If you find yourself in this situation you should try to look for services, charity.

Gautier Müllhaupt*, Lukas Hechelhammer, Daniel S. Engeler*, Sabine Güsewell, Patrick Betschart*, Valentin Zumstein*, Thomas M. Kessler§, Hans-Peter Schmid*, Livio Mordasini* and Dominik Abt*
*Department of Urology, Department of Radiology and Nuclear Medicine, Clinical Trials Unit, St. Gallen Cantonal Hospital, St Gallen and §Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland

Abstract

Objectives

To perform a post hoc analysis of in‐hospital costs incurred in a randomized controlled trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP).

Patients and Methods

In‐hospital costs arising from PAE and TURP were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs, including those arising from surgical and interventional procedures, consumables, personnel and accommodation, were analysed for all of the study participants and compared between PAE and TURP using descriptive analysis and two‐sided t‐tests, adjusted for unequal variance within groups (Welch t‐test).

Fig. 1. Cost summary for prostatic artery embolization (PAE) and TURP, grouped by mean total (A), procedural (B), and inpatient stay (C) costs. stay, inpatient stay; proc, surgical procedure; suppl, medical supplies; facil, operation facilities; phys, physician professional charges; anaest, anaesthesia; patho, pathology; lab, laboratory services; medic, medication; accom, accommodation; nurs, services by nursing specialists; admin, administrative costs, San Francisco based Ardenwood provides Christian Science nursing care.

Results

The mean total costs per patient (±sd) were higher for TURP, at €9137 ± 3301, than for PAE, at €8185 ± 1630. The mean difference of €952 was not statistically significant (P = 0.07). While the mean procedural costs were significantly higher for PAE (mean difference €623 [P = 0.009]), costs apart from the procedure were significantly lower for PAE, with a mean difference of €1627 (P < 0.001). Procedural costs of €1433 ± 552 for TURP were mainly incurred by anaesthesia, whereas €2590 ± 628 for medical supplies were the main cost factor for PAE.

Conclusions

Since in‐hospital costs are similar but PAE and TURP have different efficacy and safety profiles, the patient’s clinical condition and expectations – rather than finances – should be taken into account when deciding between PAE and TURP.

Article of the week: Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial

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 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.

Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial

Mark Plante1, Peter Gilling2, Neil Barber3, Mohamed Bidair4, Paul Anderson5, Mark Sutton6, Tev Aho7, Eugene Kramolowsky8, Andrew Thomas9, Barrett Cowan10, Ronald P. Kaufman Jr11, Andrew Trainer12, Andrew Arther12, Gopal Badlani13, Mihir Desai14, Leo Doumanian14, Alexis E. Te15, Mark DeGuenther16 and Claus Roehrborn17

 

1University of Vermont Medical Center, Burlington, VT, USA, 2Tauranga Urology Research, Tauranga, New Zealand, 3Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK, 4San Diego Clinical Trials, San Diego, CA, USA, 5Royal Melbourne Hospital, Melbourne, Vic., Australia, 6Houston Metro Urology, Houston, TX, USA, 7Addenbrookes Hospital, Cambridge University Hospitals, Cambridge, UK, 8Virginia Urology, Richmond, VA, USA, 9Princess of Wales Hospital, Bridgend, Wales, UK, 10Urology Associates, P.C., Englewood, CO, 11Albany Medical College, Albany, NY, 12Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, 13Wake Forest School of Medicine, Winston-Salem, NC, 14Institute of Urology, University of Southern California, Los Angeles, CA, 15Weill Cornell Medical College, New York, NY, 16Urology Centers of Alabama, Birmingham, AL, and 17Department of Urology, UT Southwestern Medical Center, University of Texas Southwestern, Dallas, TX, USA

 

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Abstract

Objective

To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH.

Methods

We conducted prespecified and post hoc exploratory subgroup analyses from a double‐blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien–Dindo persistent grade 1 or grade ≥2 surgical complications.

Results

For men with larger prostates (50–80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post‐void residual urine volume.

Conclusions

In men with moderate‐to‐severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.

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Editorial: A novel robotic procedure for bladder outlet obstruction

We have become used to talking about robotic surgery in urology when we really mean robot‐assisted surgery. The novel aquablation procedure (AquaBeam®) for bladder outlet obstruction (BOO) described by Plante et al. [1] is executed by a robotically controlled waterjet system, conducting a pre‐planned image‐guided resection once the radiological parameters have been entered into the system. This is performed under real‐time ultrasonography guidance. It will deliver a standardized way of carrying out the surgery and will, to a large extent, take away the surgical learning curve whilst introducing a new imaging learning curve.

The present study [1] is an analysis of pre‐planned and exploratory subsets of patients from the WATER study [2], and confirms data from earlier studies [3,4]. The study suggests that, compared with TURP, aquablation is particularly effective in improving both LUTS and bother in the medium‐sized to larger prostate (50–80 mL) and in potentially more challenging prostates such as those with large middle lobes or middle lobe obstruction (judged at pre‐procedure cystoscopy).

It is suggested that the ability to map the resection plane surgically may enable the preservation of key anatomical landmarks and preserve normal sexual function. In this study, anejaculation occurred in only 2% of patients with larger prostates (>50 mL) in the aquablation group compared with 41% of comparable patients undergoing TURP (P < 0.001). The rate of anejaculation however appeared relatively higher in the overall aquablation group, at 10%, compared with 36% in the overall TURP group (P < 0.001). A prostate volume between 30 and 80 mL was an inclusion criterion for the WATER study. This procedure therefore appears to give the best possible rate of anejaculation in a resective surgical intervention in patients with a larger prostate and may have less advantage in patients with a smaller prostate.

Interestingly, the relative overall symptom relief advantage of aquablation over TURP was also not proven in men with smaller prostates; TURP may be equally effective at removing obstructing tissue in smaller as compared to larger prostates. It is not yet clear whether aquablation would not be recommended for prostates below a certain size. In the more recent WATER II study in 101 men with a mean prostate volume of 107 mL, aquablation was also shown to be feasible and safe in men with large prostates (80–150 mL) [5].

There will always be a possible downside to novel treatments and this may relate to poor radiological data entry which may, in turn, lead to sphincter damage, although this has not been an issue in the carefully controlled studies to date. There are also reports of troublesome postoperative bleeding in some cases, although haemostasis can be effectively achieved via a catheter balloon tamponade and traction device or by electrocautery [5,6].

Unlike most other surgical treatments for BOO, the resection times for aquablation are almost independent of prostate volume, although the overall operating time is similar to that of TURP, with the majority of the time being spent in the set up and image planning.

The principal study (WATER) [2] on which this sub‐analysis by Plante et al. is based is an example of a high‐quality randomized controlled trial but still represents data on only 116 patients undergoing aquablation and 65 undergoing TURP; therefore, more randomized controlled trial data and long‐term effectiveness studies are clearly needed. Formal urodynamic studies and trials in patients with even larger prostates would also be appropriate. In addition, there are still few published data on the cost‐effectiveness of aquablation, although it is likely to be in the range of higher‐cost laser ablation therapies.

With better radiology and machine learning or artificial intelligence, this technique may lead to truly standardized BOO surgery with more complete resection and may thereby reduce outcome variability.

References

  1. Plante, MGilling, PBarber, N et al. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial. BJU Int 2019123651– 60
  2. Gilling, PBarber, NBidair, M et al. WATER: a double‐blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol 20181991252– 61
  3. Gilling, PReuther, RKahokehr, A et al. Aquablation ‐ image‐guided robot‐assisted waterjet ablation of the prostate: initial clinical experience. BJU Int 2016117923– 9
  4. Gilling, PAnderson, PTan, AAquablation of the prostate for symptomatic benign prostatic hyperplasia: 1‐year results. J Urol 20171971565– 72
  5. Desai, MBidair, MBhojani, N et al. WATER II (80‐150 mL) procedural outcomes. BJU Int 2019;123106– 12
  6. Aljuri, NGilling, PRoehrborn, CHow I do it: balloon tamponade of prostatic fossa following Aquablation. Can J Urol 2017248937– 40

 

Article of the Month: The UK‐ROPE Study

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. retainedfirefighter provides more articles like this one. Follow for more articles like this one songsforromance .

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is 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 .

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

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Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. If you want more articles like this one follow us at salbreux-pesage . IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non‐target embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy‐one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights.Here excelpasswordrecovery you can check the best articles of the month.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone‐beam computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients’ symptoms, requirements and anatomical variation.

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Editorial: Prostate Artery Embolization

Andrea Tubaro, in his editorial for European Association of Urology 2006 [1], discussed the paradigm shift in the surgical management of BPH from open surgery to TURP, and postulated that more refined and less invasive techniques would further dictate the treatment pathway to reduce cost, manage more high-risk surgical cases and reduce blood loss in a population that increasingly is on antithrombotic and anticoagulant medication, to ease the management of large prostates, and to manage BPH as a day case procedure [1].

Interventional radiology has been at the forefront of minimally invasive procedures. In 1953, Seldinger [2] published his ingenious method of introducing a catheter into the vascular system after obtaining needle access and, 10 years later, Dotter recognized the potential of catheters to be used in performing intravascular surgery [3]. Superselective prostate artery embolization (PAE) was first described by DeMeritt et al. [4]. Pisco et al. [5] from Portugal and Carnevale et al. [6] from Brazil have rightly been credited with the development of the clinical service for PAE in BPH. The study by Pisco et al. in 2016, in 630 consecutive patients with moderate to severe LUTS refractory to medical therapy for at least 6 months, showed 81.9% medium-term and 76.3% long-term clinical success rates, with no urinary incontinence or sexual dysfunction reported. Carnevale et al. [6], in 2014, described a modified PAE technique that can lead to greater ischaemia and infarction of the prostate gland with the possibility of better clinical outcomes [6].

In this edition of BJUI, the UK Register of Prostate Embolization (ROPE) study [7] provides evidence for the efficacy and safety for PAE for LUTS secondary to BPH and makes an indirect comparison with TURP. What is strikingly unique and to be applauded in this registry is the collaboration between the British Society of Interventional Radiology, the BAUS and National Institute of Clinical Excellence (NICE).

A total of 305 patients across 17 UK centres were enrolled, and results were analysed over 12 months. They noted that patients who underwent PAE had a statistically significant improvement in urinary flow rate and reduction in prostate volume after the procedure. In terms of IPSS and quality-of-life improvement, there was no evidence of PAE being non-inferior to TURP. Seventy-one percent of PAE cases were performed as outpatients or day cases. By contrast, 80% of TURPs required at least one night of hospital stay and a majority two nights [7].

In April 2018, NICE revised their guidelines and have now approved PAE with certain recommendations [8].

The key to successful PAE, in our opinion, is careful patient selection. At our centre, we receive tertiary referrals of patients with very large prostates, many of whom are comorbid and elderly. We embraced the option of PAE and were delighted to be able to contribute a number of cases to the ROPE study. Our overall experience is now in excess of 200 cases and we are aware that some patients will do well, others less well. It is becoming clearer who those patients may be; those who do well tend to be those with the larger prostate with large lateral lobes and adenomatous predominant BPH, without a significant middle lobe, with big prostate vessels and with lower risk of significant renal insufficiency. The large middle lobes can ball-valve and still obstruct, and preoperative arterial CT could identify those with heavily calcified, severely diseased internal iliac arteries that may be difficult to embolize. Nonetheless, those patients who are at highest risk from surgery and those who wish to minimize the risks of sexual dysfunction or incontinence may justifiably opt for PAE as a less invasive outpatient procedure. And why should they not? For many, simply the opportunity to avoid long-term medication with a-blockers or 5-a-reductase inhibitors is the real benefit, and undergoing PAE does not exclude one from surgery afterwards.

Level 1 evidence is of course a fundamental requirement for a change in definitive practice; the ROPE study is a comparative cohort of two fundamentally different procedures. Our institute is a surgical centre for the management of massive BPH and we are convinced that PAE has a place in the management of some of our patients, but could prevention be better than cure? Ambitious it may be, but who is to say whether early PAE in symptomatic patients might reduce the progression of clinical BPH, avoiding the morbidity and cost of long-term medical treatment culminating in surgery. Perhaps the real challenge highlighted by the ROPE study is that the time has come to consider a randomized controlled trial of prostate embolization vs early non-surgical treatment of BPH (short title ‘PREVENT-BPH’), with randomization to PAE or either a-blockers and/or 5-a-reductase inhibitors or placebo. The ROPE study suggests that PAE at the least deserves a randomized controlled trial including it vs other non-invasive treatments.

Tarun Sabharwal and Rick Popert
Guy’s and St Thomas’ Hospital, London, UK

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References

  1. Tubaro A. BPH treatment: a paradigm shift. Eur Urol 2006; 49: 939–41
  2. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol 1953; 39: 368–76
  3. Dotter CT, Judkins MP. Transluminal treatment of atherosclerotic obstructions: description of a new technique and preliminary report of its applications. Circulation 1964; 30: 654–70
  4. DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol 2000; 11: 767–70
  5. Pisco JM, Bilhim T, Pinheiro LC et al. Medium-and long-term outcome of prostate artery embolization for patients with benign prostatic hyperplasia: results in 630 patients. J Vasc Interv Radiol 2016; 27: 1115–22
  6. Carnevale FC, Moreira AM, Antunes AA. The “PErFecTED Technique”: proximal embolisation first, then embolise distal for benign prostatic hyperplasia. Cardiovasc Intervent Radiol 2014; 37: 1602–5
  7. Ray AF, Powell J, Speakman MJ et al. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int 2018; 122: 270–82
  8. NICE Guidance. Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int 2018;121: 825-34

 

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