Consensus statement on the interhospital transfer of patients with acute aortic syndrome: TRAVERSING Delphi study.

BACKGROUND: Standardisation of referral pathways and the transfer of patients with acute aortic syndromes (AAS) to regional centres are recommended by NHS England in the Acute Aortic Dissection Toolkit. The aim of the Transfer of Thoracic Aortic Vascular Emergencies to Regional Specialist INstitutes Group study was to establish an interdisciplinary consensus on the interhospital transfer of patients with AAS to specialist high-volume aortic centres. METHODS: Consensus on the key aspects of interhospital transfer of patients with AAS was established using the Delphi method, in line with Conducting and Reporting of Delphi Studies guidelines. A national patient charity for aortic dissection was involved in the design of the Delphi study. Vascular and cardiothoracic surgeons, emergency physicians, interventional radiologists, cardiologists, intensivists and anaesthetists in the United Kingdom were invited to participate via their respective professional societies. RESULTS: Three consecutive rounds of an electronic Delphi survey were completed by 212, 101 and 58 respondents, respectively. Using predefined consensus criteria, 60 out of 117 (51%) statements from the survey were included in the consensus statement. The study concluded that patients can be taken directly to a specialist aortic centre if they have typical symptoms of AAS on the background of known aortic disease or previous aortic intervention. Accepted patients should be transferred in a category 2 ambulance (response time <18 min), ideally accompanied by transfer-trained personnel or Adult Critical Care Transfer Services. A clear plan should be agreed in case of a cardiac arrest occurring during the transfer. Patients should reach the aortic centre within 4 hours of the initial referral from their local hospital. CONCLUSIONS: This consensus statement is the first set of national interdisciplinary recommendations on the interhospital transfer of patients with AAS. Its implementation is likely to contribute to safer and more standardised emergency referral pathways to regional high-volume specialist aortic units.

Endovascular aneurysm repair offers a survival advantage and is cost-effective compared with conservative management in patients physiologically unfit for open repair.

OBJECTIVE: The endovascular aneurysm repair-2 (EVAR-2) trial suggested that EVAR in patients unfit for open surgical repair (OSR) failed to provide a significant overall survival advantage compared with conservative management. The aim is to compare survival and cost-effectiveness in patients with poor cardiopulmonary exercise test (CPET) metrics who underwent EVAR or were managed conservatively. METHODS: A prospective database of all CPETs (1435 patients) performed to assess preoperative fitness for abdominal aortic aneurysm repair was maintained. A total of 350 patients deemed unfit for OSR underwent EVAR or were managed conservatively. A 1:1 propensity-matched analysis incorporating age, gender, anaerobic threshold, and aneurysm size was used to compare survival. Cost-effectiveness analysis was based on the economic model for the National Institute for Health and Care Excellence clinical guideline on abdominal aortic aneurysm treatment. RESULTS: Propensity matching produced 122 pairs of patients in the EVAR and conservative management groups. The median overall survival for the EVAR group was significantly longer than that for the conservative management group (84 vs 30 months, P < .001). One-, three-, and five-year mortality in the EVAR group was 7%, 40%, and 68%, respectively, compared with 25%, 68%, and 82% in the conservative management group, all P < .001. The increment cost-effectiveness ratio for EVAR was £8023 (US$11,644) per quality-adjusted life year gained compared with £430,602 (US$624,967) in the National Institute for Health and Care Excellence guideline, which is based on EVAR-2 results. CONCLUSIONS: EVAR offers a survival advantage and is cost-effective in selected patients deemed unfit for OSR based on CPET compared with conservative management.

Long-Term Evaluation of Percutaneous Groin Access for EVAR.

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) has been shown to have high success rates, shorter operating times and length of stay compared to open access. However, there exists a lack of long-term follow-up data on these patients, and questions remain regarding longer-term outcomes. This study aims to assess the long-term complications and evolution of accessed vessels post-PEVAR. METHODS: Sixty-one cases of bilateral PEVAR (122 groins) with > 36 months follow-up were analysed. Vessel diameter, calcification, dissection, lymphocele, pseudoaneurysm and thrombus formation were reviewed at 30th day and at the most recent follow-up CT. Notes were reviewed for groin infections, haematomas and nerve injury. Complications were considered 'major' if they required intervention or treatment. RESULTS: Mean follow-up time from procedure to most recent scan was 49.9 months. There were no major short- or long-term complications. The early complication rate was 9.8%, with six pseudoaneurysms, four dissections, one thrombus, one nerve injury and no lymphoceles, haematomas or groin infections. The long-term complication rate was 0.8%, with only one pseudoaneurysm. The remainder of early complications resolved naturally without intervention. Accessed vessel showed significantly (P ≤ 0.05) increased diameter and calcification between 30th day and last follow-up scan. CONCLUSION: This study provides the largest clinical cohort and the longest mean follow-up time reported in the literature and demonstrates the long-term safety of PEVAR. PEVAR has a very low long-term complication rate, without any major complications in our cohort. The accessed common femoral arteries do not show stenosis or thrombosis. Minor short-term complications appear to gradually resolve without intervention. Larger multi-centre studies are recommended.

A daily topical decontamination regimen reduces catheter-related bloodstream infections in haematology patients.

OBJECTIVE: To assess impact of a topical decontamination regimen on rates of catheter-related bloodstream infections (CRBSI) in intensively-treated haematology patients. METHODS: A historically-controlled cohort study was used to evaluate the effect of applying chlorhexidine or Octenisan® body washes and nasal Prontoderm® ointment for 5 days around the time of Hickman line insertion on the incidence of CRBSI and infection-free catheter time. Lines inserted during a 24 month period prior to implementation of the decolonisation regimen were compared with those inserted during a 12 month period after the intervention was applied. RESULTS: During the post-intervention period, 163 lines were inserted in 147 patients, compared to 303 lines in 242 patients in the pre-intervention period. CRBSI rates in treated and untreated patients respectively were 6.8 and 35.0 cases per 10,000 line-days by 21 days (p = 0.009), and 14.4 and 26.0 cases respectively per 10,000 line-days by 180 days (p = 0.025). The incidence rate of Staphylococcus aureus CRBSI in treated and untreated patients were 0.0 and 4.6 cases per 10,000 line-days respectively (p = 0.012). Multivariable Cox regression estimated an 81% probability (95% confidence interval 74%-85%) that a treated line develops a CRBSI later than an untreated line by 21 days post-insertion. CONCLUSION: Implementation of this safe and effective topical decontamination regimen enhances routine CRBSI-prevention measures for haematology patients requiring central venous line insertion.

Ten-year experience of retrievable inferior vena cava filters in a tertiary referral center.

PURPOSE: A significant proportion of patients undergoing surgery have an increased incidence of acute pulmonary embolus (PE). We analyzed all patients who had a retrievable inferior vena cava (IVC) filter placed preoperatively for PE prophylaxis and investigated the long-term outcomes of the patients who did not have their filter removed. METHODS: Patients who underwent retrievable IVC filter insertion and attempted removal were identified from the radiology information systems database in a large tertiary referral university teaching hospital. Results of all clinical investigations (including computed tomography, magnetic resonance imaging, ultrasonography, and plain radiography) while the IVC filters were in situ were reviewed. RESULTS: In total, 393 retrievable IVC filters were inserted, 254 with the indication of preoperative thromboembolic prophylaxis. Recurrent PE was reported in five patients (1.9%) despite the IVC filter. Of the 254 retrievable filters inserted prior to surgery, an attempt at retrieval was made in 168 filters (66.1%). Successful retrieval at the first attempt occurred in 143 cases (85.1%), while 25 cases failed or were aborted (14.9%). No attempt at retrieval was made in 86 (33.9%) patients and a significant proportion of these patients had undergone cancer surgery (P < 0.0107). In those patients where there was no attempt at retrieval, there was an association between cancer surgery and a shorter absolute survival time (P < 0.0001). CONCLUSION: The majority of attempted filter retrievals were successful, and a proportion of nonretrieved IVC filters are accounted for in patients who underwent cancer surgery and ultimately died with the filter in situ. A departmental protocol is recommended to ensure the filter is removed where appropriate and possible.

Hepatic Tract Plug-Embolisation After Biliary Stenting. Is It Worthwhile?

PURPOSE: PTC and stenting procedures are associated with significant risks including life-threatening haemorrhage, sepsis, renal failure and high mortality rates. PTC tract closure methods are utilised to reduce haemorrhagic complications despite little evidence to support their use. The current study assesses the incidence of haemorrhagic complications following PTC and stenting procedures, both prior to and following the introduction of a dedicated expanding gelatin foam-targeted embolisation liver tract closure technique. MATERIALS AND METHODS: Haemorrhagic complications were retrospectively identified in patients undergoing PTC procedures both prior to (subgroup 1) and following (subgroup 2) the introduction of a dedicated targeted liver tract closure method between 9/11/2010 and 10/08/2012 in a single tertiary referral centre. Mean blood Hb decrease following PTC was established in subgroups 1 and 2. Kaplan-Meier life-table analysis was performed to compare survival outcomes between subgroups using the log-rank test. RESULTS: Haemorrhagic complications were significantly reduced following the introduction of the targeted PTC tract closure method [(12 vs. 3 % of subgroups 1 (n = 101) and 2 (n = 92), respectively (p = 0.027)]. Mean blood Hb decrease following PTC was 1.40 versus 0.68 g/dL in subgroups 1 and 2, respectively (p = 0.069). 30-day mortality was 14 and 12 % in subgroups 1 and 2, respectively. 50 % of the entire cohort had died by 174 days post-PTC. CONCLUSION: Introduction of liver tract embolisation significantly reduced haemorrhagic complications in our patient cohort. Utilisation of this method has the potential to reduce the morbidity and mortality burden associated with post-PTC haemorrhage by preventing bleeding from the liver access tract.

Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension.

BACKGROUND: The objective of this study was to examine the safety and intraocular pressure (IOP)-lowering efficacy of a fixed combination of brinzolamide 1% + brimonidine 0.2% (BBFC) after six months of treatment in patients with open-angle glaucoma or ocular hypertension. METHODS: This was a randomized, multicenter, double-masked, three-month, three-arm contribution-of-elements study with a three-month safety extension. Patients were randomly assigned 1:1:1 to treatment with BBFC, brinzolamide 1%, or brimonidine 0.2% after a washout period. Patients dosed their study medications three times daily at 8 am, 3 pm, and 10 pm for six months. Patients returned for visits at two weeks, six weeks, three months, and six months. IOP measurements were used to assess efficacy. Safety assessments were adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, perimetry, fundus parameters, and cardiac parameters. RESULTS: A total of 690 patients were randomized. Six-month mean IOP values were similar to those at three months, when the mean IOP in patients treated with BBFC was significantly lower than that of either monotherapy group. A total of 175 patients experienced at least one treatment-related adverse event (BBFC, 33.0%; brinzolamide, 18.8%; brimonidine, 24.7%), eight of which were severe, and five resulted in discontinuation. Seventy-seven patients discontinued participation due to treatment-related adverse events (BBFC, 17.2%; brinzolamide, 2.1%; brimonidine, 14.5%). There were 21 serious adverse events (n = 7 in each group), none of which was related to treatment. Resting mean pulse and blood pressure with BBFC were similar to those with brimonidine, demonstrating modest, clinically insignificant decreases. No new or increased risks were identified with use of BBFC relative to either monotherapy. CONCLUSION: This study showed that, after six months of treatment, the safety profile of BBFC was similar to that of its individual components and its IOP-lowering activity was similar to its efficacy at three months, when it was superior to both brinzolamide 1% alone and brimonidine 0.2% alone.

Assessment of reverse flow as a means of cerebral protection during carotid artery stent placement with diffusion-weighted and transcranial Doppler imaging.

PURPOSE: To assess the effectiveness of flow reversal as an alternative means of cerebral protection by using transcranial Doppler recordings and diffusion-weighted imaging (DWI) as surrogate markers of brain injury. MATERIALS AND METHODS: Eighteen patients with symptomatic carotid artery disease were recruited. Magnetic resonance imaging was performed before the intervention and at 3 and 24 hours and 30 days after the intervention to detect new ischemic lesions with DWI. Transcranial Doppler recordings were made during the procedure to assess for microembolic signals (MESs). Data were compared against data from a historical control cohort of patients who underwent CAS placement with or without filter protection (n = 15 each) under the same protocol in a different study. RESULTS: There were fewer periprocedural new lesions on DWI in the reverse-flow cohort compared with the historical control cohort with filter protection (P = .084). Reverse flow revealed significantly fewer MESs during the whole procedure compared with the filter-protected group (P = .01) but not the unprotected group (P = .55). There was a marked decrease in MES counts for reverse flow protection during the embologenic stages of the procedure (P = .004). CONCLUSIONS: Use of the reverse flow device was associated with fewer overall lesions on DWI and proportionately fewer positive scans compared with the use of filter-type devices (P = .08, not significant). Transcranial Doppler recordings demonstrated a significant reduction in embolization to the brain during carotid artery stent placement with the use of reverse-flow cerebral protection.

Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%.

PURPOSE: This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension. PATIENTS AND METHODS: In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation. RESULTS: A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P≤0.005) across all time points. At the 2- and 6-week supportive endpoints, mean IOP of the BBFC group was significantly lower at all time points than the mean IOP of either the brinzolamide group (P≤0.01) or the brimonidine group (P<0.0001). A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n=58, 26.2%; brinzolamide group, n=44, 18.8%; brimonidine group, n=41, 17.4%), the majority of which were ocular AEs. CONCLUSIONS: This study demonstrated that BBFC has significantly superior IOP-lowering activity compared with either brinzolamide 1% or brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension while providing a safety profile which is consistent with that of the individual components.

Monitoring the use and outcomes of new devices and procedures: how does coding affect what Hospital Episode Statistics contribute? Lessons from 12 emerging procedures 2006-10.

BACKGROUND: New devices and procedures are often introduced into health services when the evidence base for their efficacy and safety is limited. The authors sought to assess the availability and accuracy of routinely collected Hospital Episodes Statistics (HES) data in the UK and their potential contribution to the monitoring of new procedures. METHODS: Four years of HES data (April 2006-March 2010) were analysed to identify episodes of hospital care involving a sample of 12 new interventional procedures. HES data were cross checked against other relevant sources including national or local registers and manufacturers' information. RESULTS: HES records were available for all 12 procedures during the entire study period. Comparative data sources were available from national (5), local (2) and manufacturer (2) registers. Factors found to affect comparisons were miscoding, alternative coding and inconsistent use of subsidiary codes. The analysis of provider coverage showed that HES is sensitive at detecting centres which carry out procedures, but specificity is poor in some cases. CONCLUSIONS: Routinely collected HES data have the potential to support quality improvements and evidence-based commissioning of devices and procedures in health services but achievement of this potential depends upon the accurate coding of procedures.

Plaque hemorrhage is a marker of thromboembolic activity in patients with symptomatic carotid disease.

PURPOSE: To assess whether carotid plaque hemorrhage depicted with magnetic resonance (MR) imaging was associated with thromboembolic activity as assessed with transcranial Doppler imaging. MATERIALS AND METHODS: The local research ethics committee approved the study, and all patients gave informed written consent. Between April 2005 and December 2006, patients with high-grade symptomatic carotid stenosis were prospectively recruited. All underwent MR imaging of the carotid arteries for plaque hemorrhage and diffusion-weighted imaging of the brain. Transcranial Doppler imaging of the symptomatic carotid artery was performed over 1 hour to assess the presence of microembolic signal. To determine the relationship between the presence of plaque hemorrhage and diffusion-weighted imaging-positive signal and presence of microembolic signal, a logistic regression analysis was performed. RESULTS: Fifty-one patients (23 women and 28 men; mean age ± standard deviation, 72 years ± 11) underwent complete MR imaging; 46 (86%) of these patients underwent complete transcranial Doppler imaging. In 32 (63%) patients, there was plaque hemorrhage in the index carotid artery. The presence of plaque hemorrhage increased the risk for ipsilateral abnormalities at diffusion-weighted imaging (odds ratio, 6.2 [95% confidence interval: 1.7, 21.8]; P < .05). Multiple diffusion-weighted imaging-depicted abnormalities of multiple ages were present exclusively in patients with plaque hemorrhage shown at MR imaging (12 of 32 [38%] patients with plaque hemorrhage versus none of 19 patients without plaque hemorrhage; P < .05). The presence of plaque hemorrhage also increased the presence of microembolic signal (odds ratio, 6.0 [95% confidence interval: 1.8, 19.9]; P = .003). CONCLUSION: In patients with carotid plaque hemorrhage demonstrated at MR imaging, there was increased spontaneous microembolic activity at transcranial Doppler imaging and cerebral ischemic lesion patterns suggestive of recurrent embolic events; these findings suggest that plaque hemorrhage shown at MR imaging might be a marker of thromboembolic activity and further validate the usefulness of carotid imaging in identifying patients with active carotid arterial disease.

Cerebral misery perfusion diagnosed using hypercapnic blood-oxygenation-level-dependent contrast functional magnetic resonance imaging: a case report.

INTRODUCTION: Cerebral misery perfusion represents a failure of cerebral autoregulation. It is an important differential diagnosis in post-stroke patients presenting with collapses in the presence of haemodynamically significant cerebrovascular stenosis. This is particularly the case when cortical or internal watershed infarcts are present. When this condition occurs, further investigation should be done immediately. CASE PRESENTATION: A 50-year-old Caucasian man presented with a stroke secondary to complete occlusion of his left internal carotid artery. He went on to suffer recurrent seizures. Neuroimaging demonstrated numerous new watershed-territory cerebral infarcts. No source of arterial thromboembolism was demonstrable. Hypercapnic blood-oxygenation-level-dependent-contrast functional magnetic resonance imaging was used to measure his cerebrovascular reserve capacity. The findings were suggestive of cerebral misery perfusion. CONCLUSIONS: Blood-oxygenation-level-dependent-contrast functional magnetic resonance imaging allows the inference of cerebral misery perfusion. This procedure is cheaper and more readily available than positron emission tomography imaging, which is the current gold standard diagnostic test. The most evaluated treatment for cerebral misery perfusion is extracranial-intracranial bypass. Although previous trials of this have been unfavourable, the results of new studies involving extracranial-intracranial bypass in high-risk patients identified during cerebral perfusion imaging are awaited.Cerebral misery perfusion is an important and under-recognized condition in which emerging imaging and treatment modalities present the possibility of practical and evidence-based management in the near future. Physicians should thus be aware of this disorder and of recent developments in diagnostic tests that allow its detection.

Leukoaraiosis predicts the need for intraoperative shunt placement during carotid endarterectomy.

OBJECTIVES: White matter hyperintense lesions (WMHLs) are related to age, hypertension, and ischemia. They increase the risk of stroke in natural history and perioperatively during carotid endarterectomy. This may reflect an association with impaired cerebral hemodynamics. Hence, the authors studied whether ipsilateral WMHLs predict shunt requirement on clamping as an indicator of hemodynamic compromise. DESIGN AND METHODS: A retrospective analysis was done in patients with symptomatic and severe carotid stenosis (>60%). Ipsilateral WMHL volumes were calculated from magnetic resonance imaging scans and association studied with the requirement of an intraoperative shunt. RESULTS: Seventy patients were included. Twelve (17%) patients required shunting and 2 developed perioperative strokes. Patients requiring shunting had a larger WMHL volume (adjusted means = 16.2 +/- 2.9 mL compared with 8.7 +/- 1.2 mL for the nonshunt group; P = .020). CONCLUSIONS: Ipsilateral WMHL volume is a significant predictive factor for shunt requirement during carotid endarterectomy. This may reflect cerebral hemodynamic compromise.

Carotid intraplaque hemorrhage detected by magnetic resonance imaging predicts embolization during carotid endarterectomy.

BACKGROUND: Microembolization detected during the dissection phase of carotid endarterectomy (CEA) is associated with plaque instability and might be associated with perioperative morbidity. Intraplaque hemorrhage is found in unstable plaques and is detectable using magnetic resonance imaging (MRI). We aimed to ascertain whether intraplaque hemorrhage as seen on carotid MRI predicts particulate embolization in the dissection phase of CEA. METHODS: Patients with high-grade symptomatic carotid stenosis undergoing CEA were prospectively enrolled. All underwent preoperative MRI assessment of the carotid arteries for intraplaque hemorrhage and transcranial Doppler scanning during the dissection phase of the CEA to assess the presence of microembolic signals. Associations between intraplaque hemorrhage and intraoperative microembolic signals were studied. RESULTS: Analysis was undertaken on 60 participants; of these, 36 (60%) showed ipsilateral carotid MRI intraplaque hemorrhage, and 24 (40%) did not. Microembolic signals were detected during the dissection phase in 23 (38.3%) participants, and 19 had MRI-detected intraplaque hemorrhage. The association between carotid intraplaque hemorrhage and the presence of dissection phase microembolic signals was significant (odds ratio [OR], 5.6; 95% confidence interval [CI], 1.6 to 19.7, P = .007), even after controlling for age, sex, individual surgeon, degree of stenosis, and delay from symptom to CEA (adjusted OR, 5.8; 95% CI, 1.1 to 30.4, P = .037). CONCLUSION: Intraplaque hemorrhage as detected by carotid MRI predicts particulate embolization during the dissection phase of CEA. This imaging technique can be used to identify patients with increased intraoperative thromboembolic risk, and this could influence preventive strategies.