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Multicenter experience with photoselective vaporization of the prostate on men taking novel oral anticoagulants.

ABSTRACT: Objective:Photoselective vaporization of the prostate (PVP) is a widely performed surgical procedure for benign prostatic obstruction. This approach has become particular favoured for men on anti-platelet and anticoagulation agents such as clopidogrel and warfarin but there is minimal published experience in the setting of novel oral anticoagulants (NOACs). This study was to examine the perioperative outcomes in men on NOACs undergoing PVP, with particular reference to perioperative morbidity. Methods:A retrospective analysis of PVP datasets was undertaken from three centres in Sydney (Australia), Toulouse (France) and Boston (USA). Subjects who had been treated whilst on NOACs without discontinuation or bridging were identified. Perioperative outcomes and treatment parameters were examined and morbidity recorded according to Clavien-Dindo (CD) classification. Results:There were a total of 20 subjects who had undergone PVP whilst NOACs had been continued during the perioperative period. The mean age was 77±6.5 years. The mean prostate volume, energy utilization and vaporisation time was 94±56 mL, 301±211 kJ, and 35±21 min respectively. The mean postoperative duration of catheterization and duration of hospitalization was 2.2±2.4 days and 2.4±2.4 days respectively. There was a single episode of urinary tract infection and four subjects required re-catheterisation for non-hematuric retentions. Conclusions:This study supports the safety of men on NOACs undergoing PVP. Whilst this study represents the largest experience of PVP in these men, larger studies are necessary to confirm the safety of PVP in this group of men undergoing BPH-related surgery.

SUBMITTER: Sachs B

PROVIDER: S-EPMC7498936 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Multicenter experience with photoselective vaporization of the prostate on men taking novel oral anticoagulants.

Sachs Brooke B Misrai Vincent V Tabatabaei Shahin S Woo Henry H HH

Asian journal of urology 20190730 4

<h4>Objective</h4>Photoselective vaporization of the prostate (PVP) is a widely performed surgical procedure for benign prostatic obstruction. This approach has become particular favoured for men on anti-platelet and anticoagulation agents such as clopidogrel and warfarin but there is minimal published experience in the setting of novel oral anticoagulants (NOACs). This study was to examine the perioperative outcomes in men on NOACs undergoing PVP, with particular reference to perioperative morb ...[more]

PMID: 32995278

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Project description:BackgroundAs an alternative to transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP) provides a bloodless, relatively painless relief of lower urinary tract symptoms for men with benign prostatic hyperplasia. Following a review of the evidence in 2006, the Ontario Health Technology Advisory Committee recommended that a study be conducted to evaluate PVP in Ontario.ObjectivesTo compare the clinical effectiveness, safety, cost-effectiveness, and budget impact of PVP compared to conventional TURP for the treatment of benign prostatic hyperplasia in Ontario.MethodsA prospective, nonrandomized trial was conducted in 3 Ontario centres. Consenting subjects were assessed at baseline and 1, 3, and 6 months following surgery. Outcome measures included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR) volume, prostate-specific antigen (PSA), health-related quality of life (HRQOL) using the EuroQol 5 Domain questionnaire, and the Sexual Health Inventory for Men (SHIM) score. Adverse events, resource utilization, and productivity losses were also assessed. Cost-effectiveness and budget impact analyses were completed using data from the study.ResultsBetween February 2008 and August 2010, 164 subjects were enrolled in the study (n = 140 for PVP and n = 24 for TURP). Treatment outcomes were similar between the 2 groups at 6 months, with the IPSS decreasing similarly over time (P = 0.718). For other treatment outcomes (Qmax, PSA, HRQOL, SHIM) both treatments provided similar benefit over time; only changes in PVR volume favoured PVP (P = 0.018). The majority of PVP patients were managed on an outpatient basis, with only 7.1% requiring admission (all TURP subjects were inpatients). At 6 months, PVP was less costly than TURP ($3,891 versus $4,863; P = 0.001), with similar quality-adjusted life-years (0.448 versus 0.441; P = 0.658). PVP remained the most cost-effective treatment across all decision-making thresholds, with the technology costing less and providing similar clinical outcomes. Extrapolating the results to a provincial level indicated (based on an estimated case volume of 12,335 TURPs) that there is an opportunity to reallocate just over $14 million (Cdn), primarily related to the reduced need for hospital admission.LimitationsThis study was nonrandomized, and the results should be interpreted with some caution, despite generally similar baseline characteristics between the 2 groups. Recruiting individuals to the TURP arm was a challenge, resulting in a size imbalance between treatment arms.ConclusionsBased on this analysis, PVP appears to be a cost-effective alternative to TURP, providing similar clinical benefit at a lower cost to the health system.

Project description:BACKGROUND:Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged >?50?years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. METHODS:This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score?<?2), using two-tailed 95% confidence intervals. DISCUSSION:This first multicentre RCT in the field is underway to evaluate the safety and efficacy of PVP in patients with ongoing OAC therapy. The study results could influence the perioperative management of OACs in BPO surgery with a high level of evidence. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03297281 . Registered on 29 September 2017.

Project description:ObjectiveWe investigated the contribution of small vessel disease (SVD) to anticoagulant-associated intracerebral haemorrhage (ICH).MethodsClinical Relevance of Microbleeds in Stroke-2 comprised two independent multicentre observation studies: first, a cross-sectional study of patients with ICH; and second, a prospective study of patients taking anticoagulants for atrial fibrillation (AF) after cerebral ischaemia. In patients with ICH, we compared SVD markers on CT and MRI according to prior anticoagulant therapy. In patients with AF and cerebral ischaemia treated with anticoagulants, we compared the rates of ICH and ischaemic stroke according to SVD burden score during 2 years follow-up.ResultsWe included 1030 patients with ICH (421 on anticoagulants), and 1447 patients with AF and cerebral ischaemia. Medium-to-high severity SVD was more prevalent in patients with anticoagulant-associated ICH (CT 56.1%, MRI 78.7%) than in those without prior anticoagulant therapy (CT 43.5%, p<0.001; MRI 64.5%, p=0.072). Leukoaraiosis and atrophy were more frequent and severe in ICH associated with prior anticoagulation. In the cerebral ischaemia cohort (779 with SVD), during 3366 patient-years of follow-up the rate of ICH was 0.56%/year (IQR 0.27-1.03) in patients with SVD, and 0.06%/year (IQR 0.00-0.35) in those without (p=0.001); ICH was independently associated with severity of SVD (HR 5.0, 95% CI 1.9 to 12.2,p=0.001), and was predicted by models including SVD (c-index 0.75, 95% CI 0.63 to 0.85).ConclusionsMedium-to-high severity SVD is associated with ICH occurring on anticoagulants, and independently predicts ICH in patients with AF taking anticoagulants; its absence identifies patients at low risk of ICH. Findings from these two complementary studies suggest that SVD is a contributory factor in ICH in patients taking anticoagulants and suggest that anticoagulation alone should no longer be regarded as a sufficient 'cause' of ICH.Trial registrationNCT02513316.

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Multicenter experience with photoselective vaporization of the prostate on men taking novel oral anticoagulants.

Publications

Multicenter experience with photoselective vaporization of the prostate on men taking novel oral anticoagulants.

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