Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial.

BACKGROUND: Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT. METHODS: We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648. FINDINGS: Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78-1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37-0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33-0·83]). INTERPRETATION: For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Protocol for a systematic review and thematic synthesis of patient experiences of central venous access devices in anti-cancer treatment.

BACKGROUND: Three types of central venous access devices (CVADs)-peripherally inserted central catheters (PICCs), skin-tunnelled central catheters (Hickman-type devices), and implantable chest wall Ports (Ports)-are routinely used in the intravenous administration of anti-cancer treatment. These devices avoid the need for peripheral cannulation and allow for home delivery of treatment. Assessments of these devices have tended to focus on medical and economic factors, but there is increased interest in the importance of patient experiences and perspectives in this area. The aim of this systematic review is to synthesise existing research regarding patient experiences of these CVADs to help clinicians guide, prepare, and support patients receiving CVADs for the administration of anti-cancer treatment. METHOD: A systematic search of MEDLINE, Embase, and CINAHL research databases will be carried out along with a supplementary reference list search. This review will include quantitative, qualitative, and mixed methods studies published in peer-review journals, reporting some aspect(s) of patient experiences or perspectives regarding the use of PICC, Hickman, or Port CVADs for the administration of anti-cancer drugs. The methodological quality and risk of bias of included papers will be assessed using the Mixed Methods Appraisal Tool (MMAT). Relevant outcome data will be extracted from included studies and analysed using a thematic synthesis approach. DISCUSSION: The results section of the review will comprise thematic synthesis of quantitative studies, thematic synthesis of qualitative studies, and the aggregation of the two. Results will aim to offer an account of current understandings of patient experiences and perspective regarding PICC, Hickman-type, and Port devices in the context of anti-cancer treatment. Confidence in cumulative evidence will be assessed using the Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach. SYSTEMATIC REVIEW REGISTRATION: This systematic review protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number: CRD42017065851 . This protocol was prepared using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols checklist (PRISMA-P) (Shamseer et al., BMJ 349: 2015).

Executive summary of the joint position paper on renal denervation of the Cardiovascular and Interventional Radiological Society of Europe and the European Society of Hypertension.

Renal denervation (RDN) was reported as a novel exciting treatment for resistant hypertension in 2009. An initial randomized trial supported its efficacy and the technique gained rapid acceptance across the globe. However, a subsequent large blinded, sham arm randomized trial conducted in the USA (to gain Food and Drug Administration approval) failed to achieve its primary efficacy end point in reducing office blood pressure at 6 months. Published in 2014 this trial received both widespread praise and criticism. RDN has effectively stopped out with clinical trials pending further evidence. This joint consensus document representing the European Society of Hypertension and the Cardiovascular and Radiological Society of Europe attempts to distill the current evidence and provide future direction and guidance.

Effectiveness of Embolization or Sclerotherapy of Pelvic Veins for Reducing Chronic Pelvic Pain: A Systematic Review.

PURPOSE: Chronic pelvic pain (CPP) in the presence of dilated and refluxing pelvic veins is often described as pelvic congestion syndrome (PCS), although the causal relationship between pelvic vein incompetence and CPP has not been established. Percutaneous embolization is the principal treatment for PCS, with high success rates cited. This study was undertaken to systematically and critically review the effectiveness of embolization of incompetent pelvic veins. MATERIALS AND METHODS: A comprehensive search strategy encompassing various terms for pelvic congestion, pelvic pain, and embolization was deployed in 17 bibliographic databases, with no restriction on study design. Methodologic quality was assessed. The quality and heterogeneity generally precluded meta-analysis. Results were tabulated and described narratively. RESULTS: Twenty-one prospective case series and one poor-quality randomized trial of embolization (involving a total of 1,308 women) were identified. Early substantial relief from pain was observed in approximately 75% of women undergoing embolization, and generally increased over time and was sustained. Significant pain reductions following treatment were observed in all studies that measured pain on a visual analog scale. Repeat intervention rates were generally low. There were few data on the impact on menstruation, ovarian reserve, or fertility, but no concerns were noted. Transient pain was common following foam embolization, and there was a < 2% risk of coil migration. CONCLUSIONS: Embolization appears to provide symptomatic relief of CPP in the majority of women and is safe, although the quality of the evidence is low.

Renal artery sympathetic denervation: observations from the UK experience.

BACKGROUND: Renal denervation (RDN) may lower blood pressure (BP); however, it is unclear whether medication changes may be confounding results. Furthermore, limited data exist on pattern of ambulatory blood pressure (ABP) response-particularly in those prescribed aldosterone antagonists at the time of RDN. METHODS: We examined all patients treated with RDN for treatment-resistant hypertension in 18 UK centres. RESULTS: Results from 253 patients treated with five technologies are shown. Pre-procedural mean office BP (OBP) was 185/102 mmHg (SD 26/19; n = 253) and mean daytime ABP was 170/98 mmHg (SD 22/16; n = 186). Median number of antihypertensive drugs was 5.0: 96 % ACEi/ARB; 86 % thiazide/loop diuretic and 55 % aldosterone antagonist. OBP, available in 90 % at 11 months follow-up, was 163/93 mmHg (reduction of 22/9 mmHg). ABP, available in 70 % at 8.5 months follow-up, was 158/91 mmHg (fall of 12/7 mmHg). Mean drug changes post RDN were: 0.36 drugs added, 0.91 withdrawn. Dose changes appeared neutral. Quartile analysis by starting ABP showed mean reductions in systolic ABP after RDN of: 0.4; 6.5; 14.5 and 22.1 mmHg, respectively (p < 0.001 for trend). Use of aldosterone antagonist did not predict response (p > 0.2). CONCLUSION: In 253 patients treated with RDN, office BP fell by 22/9 mmHg. Ambulatory BP fell by 12/7 mmHg, though little response was seen in the lowermost quartile of starting blood pressure. Fall in BP was not explained by medication changes and aldosterone antagonist use did not affect response.

Can ovarian vein embolization cause more harm than good?

Ovarian vein embolization using embolic coils is a recognized treatment for chronic pelvic pain caused by pelvic congestion syndrome (PCS). Although it is considered a non-invasive procedure with a good safety record, there have been reported complications resulting from embolic coil migration. We present a case of embolic coil erosion of the ovarian vein discovered on laparoscopy for chronic pelvic pain.

Endovascular aneurysm repair: is imaging surveillance robust, and does it influence long-term mortality?

PURPOSE: Endovascular aneurysm repair (EVAR) is the dominant treatment strategy for abdominal aortic aneurysms. However, as a result of uncertainty regarding long-term durability, an ongoing imaging surveillance program is required. The aim of the study was to assess EVAR surveillance in Scotland and its effect on all-cause and aneurysm-related mortality. METHODS: A retrospective analysis of all EVAR procedures carried out in the four main Scottish vascular units. The primary outcome measure was the implementation of post-EVAR imaging surveillance across Scotland. Patients were identified locally and then categorized as having complete, incomplete, or no surveillance. Secondary outcome measures were all-cause mortality and aneurysm-related mortality. Cause of death was obtained from death certificates. RESULTS: Data were available for 569 patients from the years 2001 to 2012. All centers had data for a minimum of 5 contiguous years. Surveillance ranged from 1.66 to 4.55 years (median 3.03 years). Overall, 53 % had complete imaging surveillance, 43 % incomplete, and 4 % none. For the whole cohort, all-cause 5-year mortality was 33.5 % (95 % confidence interval 28.0-38.6) and aneurysm-related mortality was 4.5 % (.8-7.3). All-cause mortality in patients with complete, incomplete, and no imaging was 49.9 % (39.2-58.6), 19.1 % (12.6-25.2), and 47.2 % (17.7-66.2), respectively. Aneurysm-related mortality was 3.7 % (1.8-7.4), 4.4 % (2.2-8.9), and 9.5 % (2.5-33.0), respectively. All-cause mortality was significantly higher in patients with complete compared to incomplete imaging surveillance (p < 0.001). No significant differences were observed in aneurysm-related mortality (p = 0.2). CONCLUSION: Only half of EVAR patients underwent complete long-term imaging surveillance. However, incomplete imaging could not be linked to any increase in mortality. Further work is required to establish the role and deliverability of EVAR imaging surveillance.

Revascularization versus medical therapy for renal-artery stenosis.

BACKGROUND: Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited. METHODS: In a randomized, unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months. RESULTS: During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was -0.07x10(-3) liters per micromole per year in the revascularization group, as compared with -0.13x10(-3) liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10(-3) liters per micromole per year (95% confidence interval [CI], -0.002 to 0.13; P=0.06). Over the same time, the mean serum creatinine level was 1.6 micromol per liter (95% CI, -8.4 to 5.2 [0.02 mg per deciliter; 95% CI, -0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P=0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P=0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P=0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs. CONCLUSIONS: We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. (Current Controlled Trials number, ISRCTN59586944.)

Uterine-artery embolization versus surgery for symptomatic uterine fibroids.

BACKGROUND: The efficacy and safety of uterine-artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. METHODS: We conducted a randomized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids. The primary outcome was quality of life at 1 year of follow-up, as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). RESULTS: Patients were randomly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolization group had a shorter median duration of hospitalization than the surgical group (1 day vs. 5 days, P<0.001) and a shorter time before returning to work (P<0.001). At 1 year, symptom scores were better in the surgical group (P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolization group (12%) and 10 in the surgical group (20%) (P=0.22), mostly related to the intervention. Ten patients in the embolization group (9%) required repeated embolization or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolization group (13%) required hospitalization, 3 of them for major adverse events and 11 for reintervention for treatment failure. CONCLUSIONS: In women with symptomatic fibroids, the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients. (ISRCTN.org number, ISRCTN23023665 [controlled-trials.com].)

Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation.

PURPOSE: To report the results of a multicenter experience with the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt (TIPS) creation in which patency and clinical outcome were evaluated. MATERIALS AND METHODS: One hundred consecutive patients with portal hypertension, with a mean age of 52 years (range, 22-86 years), underwent implantation of the Viatorr TIPS stent-graft at one of three hospital centers. The indications for TIPS creation were variceal bleeding (n = 81) and refractory ascites (n = 19). Twenty patients had Child-Pugh class A disease, 46 had class B disease, and 34 had class C disease. Eighty-seven patients underwent de novo TIPS placements, with 13 treated for recurrent TIPS stenosis. Sixty-two patients were available for follow-up portal venography and portosystemic pressure gradient (PSG) measurement commencing 6 months after Viatorr stent-graft placement. RESULTS: The technical success rate was 100%. TIPS creation resulted in an immediate decrease in mean PSG (+/-SD) from 21 mm Hg +/- 6 to 7 mm Hg +/- 3. Acute repeat intervention (within 30 days) was required for portal vein thrombosis (n = 1), continued bleeding (n = 3), and encephalopathy (n = 1). The all-cause 30-day mortality rate was 12%. Two patients developed acute severe refractory encephalopathy, which led to death in one case. New or worsening encephalopathy was identified in 14% of patients. The incidence of recurrent bleeding was 8%. The cumulative survival rate at 1 year was 65%. Sixty-two patients available for venographic follow-up had a mean PSG of 9 mm Hg +/- 5 at a mean interval of 343 days (range, 56-967 days). There were four stent-graft occlusions (6%) and seven hemodynamically significant stenoses (11%), four within the stent-graft and three in the non-stent-implanted hepatic vein. The primary patency rate at 1 year by Kaplan-Meier analysis was 84%. CONCLUSIONS: This retrospective multicenter experience with the Viatorr stent-graft confirms the preliminary findings of other investigators of good technical results and improved patency compared with bare stents. Early mortality and symptomatic recurrence rates are low by historical standards. The theoretical increase in TIPS-related encephalopathy was not demonstrated. Longer-term follow-up will be required to determine whether the additional cost of the Viatorr stent-graft will be offset by reduced surveillance and repeat intervention.