Jonathan G. Moss

Results of a Retrospective Multicenter Trial of the Viatorr Expanded Polytetrafluoroethylene– covered Stent-Graft for Transjugular Intrahepatic Portosystemic Shunt Creation

PURPOSEnTo 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.nnnMATERIALS AND METHODSnOne 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.nnnRESULTSnThe 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%.nnnCONCLUSIONSnThis 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.

Comparison of Technical Success and Outcome of Tunneled Catheters Inserted via the Jugular and Subclavian Approaches

PURPOSEnTo compare the technical success and immediate and long-term outcomes of tunneled central venous catheters placed in comparative cohorts via the subclavian vein (SCV) and the internal jugular vein (IJV) routes.nnnMATERIALS AND METHODSnThis was a prospective observational single-center study of consecutive procedures. Between November 1993 and June 1995, 99 catheters were placed via the SCV and between December 1997 and July 1998, 109 catheters were placed via the IJV. Procedural data were recorded in both cohorts by completion of a proforma by the primary operator.nnnRESULTSnFollow-up data were available in 96% of the SCV and 87% of the IJV cohorts. The average procedure time was significantly shorter in the IJV group and technical success was 100% versus 97% in the SCV group, but this did not reach statistical significance. The procedure-related pneumothorax rate and the rate of symptomatic venous thrombosis were significantly lower in the IJV cohort (P = .023, P = .015). Fewer catheters were removed prematurely due to sepsis in the IJV group (P = .043).nnnCONCLUSIONSnThe IJV route is associated with comparable technical success, and lower major procedural complication and venous thrombosis rates, with fewer catheters removed prematurely. The right IJV approach with ultrasound guidance is recommended as the route of choice for the placement of tunneled central venous catheters.

Joint UK societies' 2014 consensus statement on renal denervation for resistant hypertension.

Resistant hypertension continues to pose a major challenge to clinicians worldwide and has serious implications for patients who are at increased risk of cardiovascular morbidity and mortality with this diagnosis. Pharmacological therapy for resistant hypertension follows guidelines-based regimens although there is surprisingly scant evidence for beneficial outcomes using additional drug treatment after three antihypertensives have failed to achieve target blood pressure. Recently there has been considerable interest in the use of endoluminal renal denervation as an interventional technique to achieve renal nerve ablation and lower blood pressure. Although initial clinical trials of renal denervation in patients with resistant hypertension demonstrated encouraging office blood pressure reduction, a large randomised control trial (Symplicity HTN-3) with a sham-control limb, failed to meet its primary efficacy end point. The trial however was subject to a number of flaws which must be taken into consideration in interpreting the final results. Moreover a substantial body of evidence from non-randomised smaller trials does suggest that renal denervation may have an important role in the management of hypertension and other disease states characterised by overactivation of the sympathetic nervous system. The Joint UK Societies does not recommend the use of renal denervation for treatment of resistant hypertension in routine clinical practice but remains committed to supporting research activity in this field. A number of research strategies are identified and much that can be improved upon to ensure better design and conduct of future randomised studies.

Common iliac artery access during endovascular thoracic aortic repair facilitated by a transabdominal wall tunnel.

Purpose: To describe a technique for common iliac artery (CIA) access during endovascular aortic aneurysm repair when unfavorable angulation between the CIA and the delivery sheath precludes direct arterial access. Technique: After retroperitoneal exposure of the CIA, a puncture site is chosen inferolateral to the surgical incision, and an 18-G trocar/cannula is advanced in alignment with the CIA through the anterior abdominal wall or skin of the upper thigh into the retroperitoneal space. Serial dilatation is performed over a guidewire placed through the cannula to create the subcutaneous tract. The trocar/cannula is replaced over the wire, and the CIA is punctured under direct vision. The guidewire is then advanced into the proximal aorta. A CIA arteriotomy is performed and the delivery system introduced over the guidewire through the tunnel into the iliac artery. Conclusions: Retroperitoneal exposure of the CIA with tunneled transabdominal wall delivery of the stent-graft avoids both external iliac artery injury and creation of a temporary access conduit in patients with iliac tortuosity and/or occlusive disease.

Renal artery sympathetic denervation: observations from the UK experience

BackgroundRenal 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.MethodsWe examined all patients treated with RDN for treatment-resistant hypertension in 18 UK centres.ResultsResults from 253 patients treated with five technologies are shown. Pre-procedural mean office BP (OBP) was 185/102xa0mmHg (SD 26/19; nxa0=xa0253) and mean daytime ABP was 170/98xa0mmHg (SD 22/16; nxa0=xa0186). Median number of antihypertensive drugs was 5.0: 96xa0% ACEi/ARB; 86xa0% thiazide/loop diuretic and 55xa0% aldosterone antagonist. OBP, available in 90xa0% at 11xa0months follow-up, was 163/93xa0mmHg (reduction of 22/9xa0mmHg). ABP, available in 70xa0% at 8.5xa0months follow-up, was 158/91xa0mmHg (fall of 12/7xa0mmHg). 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 22.1xa0mmHg, respectively (pxa0<xa00.001 for trend). Use of aldosterone antagonist did not predict response (pxa0>xa00.2).ConclusionIn 253 patients treated with RDN, office BP fell by 22/9xa0mmHg. Ambulatory BP fell by 12/7xa0mmHg, 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.

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

PurposeEndovascular 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.MethodsA 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.ResultsData 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 4.55xa0years (median 3.03 years). Overall, 53xa0% had complete imaging surveillance, 43xa0% incomplete, and 4xa0% none. For the whole cohort, all-cause 5-year mortality was 33.5xa0% (95xa0% confidence interval 28.0–38.6) and aneurysm-related mortality was 4.5xa0% (.8–7.3). All-cause mortality in patients with complete, incomplete, and no imaging was 49.9xa0% (39.2–58.6), 19.1xa0% (12.6–25.2), and 47.2xa0% (17.7–66.2), respectively. Aneurysm-related mortality was 3.7xa0% (1.8–7.4), 4.4xa0% (2.2–8.9), and 9.5xa0% (2.5–33.0), respectively. All-cause mortality was significantly higher in patients with complete compared to incomplete imaging surveillance (pxa0<xa00.001). No significant differences were observed in aneurysm-related mortality (pxa0=xa00.2).ConclusionOnly 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.

Cardiovascular and Interventional Radiological Society of Europe (CIRSE) position statement on renal denervation for resistant hypertension.

Hypertension is a major global healthcare challenge now recognised as the leading cause of mortality across the developed and developing world (1). Resistant hyperten- sion (systolic BP (140 mmHg on three or more medica- tions) makes up a significant minority of this group (5-15 %) and is associated with a considerably increased risk of cardiovascular events. Renal denervation (RDN) is emerging as a significant step forward in the treatment of patients with resistant hypertension. The publication of the Symplicity I and II trials has firmly established the pro- cedure with both proof of principle and short-term efficacy using randomised controlled trial methodology (2-4). Who is Eligible for RDN? At present the evidence only supports its use in resistant hypertension. This was defined in the trials as a clinic systolic blood pressure C160 mmHg (C150 mmHg in type 2 diabetes) on three or more antihypertensive medica- tions. Ideally, this should be supported with ambulatory blood pressure measurements to exclude the white coat phenomenon. In the trials, patients were excluded if the estimated GFR 45 ml/min/1.73 m 2 and local protocols should be in place if patients with an eGFR 45 ml/min/1.73 m 2 are to be treated.

Hickman catheter and implantable port devices for the delivery of chemotherapy: a phase II randomised controlled trial and economic evaluation.

Background:In the United Kingdom, totally implantable venous access systems (TIVAS) are not routinely used. Compared with Hickman catheters, these devices are more expensive and complex to insert. However, it is unclear whether the higher costs may be offset by perceived greater health benefits. This pilot trial aimed to generate relevant data to inform the design of a larger definitive randomised controlled trial.Methods:This was a phase II prospective, randomised, open trial from two UK oncology centres. The primary end point was overall complication rate. Secondary end points included individual complication rates, time to first complication and quality of life. Analysis was by intention to treat. An economic evaluation was also carried out.Results:A total of 100 patients were randomised in a 3u2009:u20091 ratio to receive a Hickman or a TIVAS. Overall, 54% of patients in the Hickman arm suffered one or more complications compared with 38% in the TIVAS arm (one-sided P=0.068). In the Hickman arm, 28% of the devices were removed prematurely due to a complication compared with 4% in the TIVAS arm. Quality of life based on the device-specific questionnaire was greater in the TIVAS arm for 13 of the 16 questions. The economic evaluation showed that Hickman arm was associated with greater mean cost per patient £1803 (95% CI 462, 3215), but similar quality-adjusted life years −0.01 (95% CI −0.15, 0.15) than the TIVAS arm. However, there is much uncertainty associated with the results.Conclusions:Compared with Hickman catheters, TIVAS may be the cost-effective option. A larger multicentre trial is needed to confirm these preliminary findings.

Exploring attitudes towards a randomised controlled trial of venous access devices – a nested pre-trial qualitative study

Purpose This pre-trial qualitative research study was carried out to explore patient and clinical staff attitudes to central venous access devices (CVADs). In addition, views about participation in a randomised controlled trial (RCT) were explored with the aim of maximising recruitment to an imminent RCT of three CVADs. Methods Three patient focus groups (each comprising three patients) and 23 interviews with clinical staff were conducted. Interviews and focus group discussions were digitally recorded, transcribed verbatim, anonymised, uploaded to the QSR NVivo10 qualitative software programme and thematically analysed. Results Analysis of focus group interviews revealed the added challenges that a CVAD poses to patients with cancer. Four key themes emerged: continuity of daily life, pain and discomfort, stigma (a mark of disgrace associated with certain conditions) and self-preservation. The findings show the impact of a CVAD on patients’ ability to manage their condition. Clinical staff interviews highlighted several potential barriers to recruitment; a lack of equipoise (genuine clinical uncertainty as to which intervention is the most beneficial), concerns about the logistics of device insertion and a perceived requirement for education and training. Conclusions This qualitative study raises awareness of key areas of concern to patients who need a CVAD for chemotherapy delivery. It was identified that there is a need for clearer patient information around CVADs. Additionally it allows investigators to identify barriers to recruitment in a timely manner in order to minimise the potential for conflict between the roles of carer and researcher and consequently, maximise recruitment to the RCT.

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.